Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-0749

2. Registrant Information.

Registrant Reference Number: 1487527

Registrant Name (Full Legal Name no abbreviations): McLaughlin Gormley King Company

Address: 8810 Tenth Ave North

City: Minneapolis

Prov / State: MN

Country: USA

Postal Code: 55427-4319

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

22-OCT-14

5. Location of incident.

Country: UNITED STATES

Prov / State: KENTUCKY

6. Date incident was first observed.

Unknown

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 1021-1704-40849

Product Name: Flea & Tick Spray for Dogs and Cats II

• Active Ingredient(s)
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • Guarantee/concentration .957 %
  • PYRETHRINS
    • Guarantee/concentration .18 %
  • PYRIPROXYFEN
    • Guarantee/concentration .125 %

---

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

DSH

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Salivating excessively
  • Symptom - Vomiting

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Ataxia

• Respiratory System
  • Symptom - Shortness of breath

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

11/19/2014 A report was forwarded for documentation. The report states that a consumer applied the product to her cats and dogs. The cats became ill, but the dogs remained asymptomatic. The cats developed respiratory problems, salivating, loss of balance, and vomiting. Consumer called back a week later, and reports that two of the cats died and one has still not recovered. She did not take the cats to a veterinarian, but did call the veterinarian. 11/21/2014 Call from the consumer. Caller used the product on 7 cats and 2 dogs several months ago. Cat #1 showed signs of ataxia, shortness of breath, drooling, and vomiting the next day after application. He did start to show signs of improvement but then passed away about 1 week after use. Caller noted that she bathed the cat but did not take him into a vet clinic. Cat #2 showed signs a few hours after application that progressively got worse until she passed away 2 days after application. The cat was showing signs of ataxia, shortness of breath, vomiting, and drooling. Cat #3 showed signs of ataxia, shortness of breath, vomiting, and drooling that started a few hours after use of the product. Caller syringe feed this cat, gave her subcutaneous fluids, and antibiotic injections, but did not seek veterinary care. She showed some improvement but then passed away a few months after the use of the product. Cat #4 showed signs of ataxia, drooling, diarrhea, and vomiting a few hours after application. He was bathed, given some antibiotics, and given Kaopectate for the diarrhea that had developed. He is still not using the litter box but seems to have recovered. Cat #5 showed signs of ataxia and drooling a few hours after use of the product. He still has some ataxia, but caller noted that he broke one of his limbs as a kitten and had a cast on for a period of time. No new or worsening symptoms have presented. Cat #6 showed signs of hair loss, drooling, ataxia, and had some seizure like activity after use. The symptoms now seem to have resolved. Cat #7 showed sings of salivation, vomiting, ataxia, and became anorexic a few hours after use. The symptoms now seem to have resolved. The 2 dogs did not show any signs after the use of the product.

---

To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. This insecticide appears to be implicated in this case simply based on a temporal but coincidental product use scenario. Incident reportedly took place several months ago. Based on the known toxicological profile of the active ingredients used in this pesticide, when this product is used in the manner described in this incident, such significant adverse effects as reported are not expected. Furthermore, these animals were never properly evaluated and treated by a DVM, nor had a necropsy been performed to determine a cause of death. The cat's prior history regarding preventative medicine such as vaccinations, deworming and feline leukemia virus was not disclosed. All cats were described as having flea infestations which also must be considered as contributing factors in their clinical outcomes.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

DSH

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Salivating excessively
  • Symptom - Vomiting

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Ataxia

• Respiratory System
  • Symptom - Shortness of breath

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

11/19/2014 A report was forwarded for documentation. The report states that a consumer applied the product to her cats and dogs. The cats became ill, but the dogs remained asymptomatic. The cats developed respiratory problems, salivating, loss of balance, and vomiting. Consumer called back a week later, and reports that two of the cats died and one has still not recovered. She did not take the cats to a veterinarian, but did call the veterinarian. 11/21/2014 Call from the consumer. Caller used the product on 7 cats and 2 dogs several months ago. Cat #1 showed signs of ataxia, shortness of breath, drooling, and vomiting the next day after application. He did start to show signs of improvement but then passed away about 1 week after use. Caller noted that she bathed the cat but did not take him into a vet clinic. Cat #2 showed signs a few hours after application that progressively got worse until she passed away 2 days after application. The cat was showing signs of ataxia, shortness of breath, vomiting, and drooling. Cat #3 showed signs of ataxia, shortness of breath, vomiting, and drooling that started a few hours after use of the product. Caller syringe feed this cat, gave her subcutaneous fluids, and antibiotic injections, but did not seek veterinary care. She showed some improvement but then passed away a few months after the use of the product. Cat #4 showed signs of ataxia, drooling, diarrhea, and vomiting a few hours after application. He was bathed, given some antibiotics, and given Kaopectate for the diarrhea that had developed. He is still not using the litter box but seems to have recovered. Cat #5 showed signs of ataxia and drooling a few hours after use of the product. He still has some ataxia, but caller noted that he broke one of his limbs as a kitten and had a cast on for a period of time. No new or worsening symptoms have presented. Cat #6 showed signs of hair loss, drooling, ataxia, and had some seizure like activity after use. The symptoms now seem to have resolved. Cat #7 showed sings of salivation, vomiting, ataxia, and became anorexic a few hours after use. The symptoms now seem to have resolved. The 2 dogs did not show any signs after the use of the product.

---

To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. This insecticide appears to be implicated in this case simply based on a temporal but coincidental product use scenario. Incident reportedly took place several months ago. Based on the known toxicological profile of the active ingredients used in this pesticide, when this product is used in the manner described in this incident, such significant adverse effects as reported are not expected. Furthermore, these animals were never properly evaluated and treated by a DVM, nor had a necropsy been performed to determine a cause of death. The cat's prior history regarding preventative medicine such as vaccinations, deworming and feline leukemia virus was not disclosed. All cats were described as having flea infestations which also must be considered as contributing factors in their clinical outcomes.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

DLH

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Salivating excessively
  • Symptom - Vomiting

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Ataxia

• Respiratory System
  • Symptom - Shortness of breath

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

11/19/2014 A report was forwarded for documentation. The report states that a consumer applied the product to her cats and dogs. The cats became ill, but the dogs remained asymptomatic. The cats developed respiratory problems, salivating, loss of balance, and vomiting. Consumer called back a week later, and reports that two of the cats died and one has still not recovered. She did not take the cats to a veterinarian, but did call the veterinarian. 11/21/2014 Call from the consumer. Caller used the product on 7 cats and 2 dogs several months ago. Cat #1 showed signs of ataxia, shortness of breath, drooling, and vomiting the next day after application. He did start to show signs of improvement but then passed away about 1 week after use. Caller noted that she bathed the cat but did not take him into a vet clinic. Cat #2 showed signs a few hours after application that progressively got worse until she passed away 2 days after application. The cat was showing signs of ataxia, shortness of breath, vomiting, and drooling. Cat #3 showed signs of ataxia, shortness of breath, vomiting, and drooling that started a few hours after use of the product. Caller syringe feed this cat, gave her subcutaneous fluids, and antibiotic injections, but did not seek veterinary care. She showed some improvement but then passed away a few months after the use of the product. Cat #4 showed signs of ataxia, drooling, diarrhea, and vomiting a few hours after application. He was bathed, given some antibiotics, and given Kaopectate for the diarrhea that had developed. He is still not using the litter box but seems to have recovered. Cat #5 showed signs of ataxia and drooling a few hours after use of the product. He still has some ataxia, but caller noted that he broke one of his limbs as a kitten and had a cast on for a period of time. No new or worsening symptoms have presented. Cat #6 showed signs of hair loss, drooling, ataxia, and had some seizure like activity after use. The symptoms now seem to have resolved. Cat #7 showed sings of salivation, vomiting, ataxia, and became anorexic a few hours after use. The symptoms now seem to have resolved. The 2 dogs did not show any signs after the use of the product.

---

To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. This insecticide appears to be implicated in this case simply based on a temporal but coincidental product use scenario. Incident reportedly took place several months ago. Based on the known toxicological profile of the active ingredients used in this pesticide, when this product is used in the manner described in this incident, such significant adverse effects as reported are not expected. Furthermore, these animals were never properly evaluated and treated by a DVM, nor had a necropsy been performed to determine a cause of death. The cat's prior history regarding preventative medicine such as vaccinations, deworming and feline leukemia virus was not disclosed. All cats were described as having flea infestations which also must be considered as contributing factors in their clinical outcomes.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Siamese

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Diarrhea
  • Symptom - Salivating excessively
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Ataxia

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

11/19/2014 A report was forwarded for documentation. The report states that a consumer applied the product to her cats and dogs. The cats became ill, but the dogs remained asymptomatic. The cats developed respiratory problems, salivating, loss of balance, and vomiting. Consumer called back a week later, and reports that two of the cats died and one has still not recovered. She did not take the cats to a veterinarian, but did call the veterinarian. 11/21/2014 Call from the consumer. Caller used the product on 7 cats and 2 dogs several months ago. Cat #1 showed signs of ataxia, shortness of breath, drooling, and vomiting the next day after application. He did start to show signs of improvement but then passed away about 1 week after use. Caller noted that she bathed the cat but did not take him into a vet clinic. Cat #2 showed signs a few hours after application that progressively got worse until she passed away 2 days after application. The cat was showing signs of ataxia, shortness of breath, vomiting, and drooling. Cat #3 showed signs of ataxia, shortness of breath, vomiting, and drooling that started a few hours after use of the product. Caller syringe feed this cat, gave her subcutaneous fluids, and antibiotic injections, but did not seek veterinary care. She showed some improvement but then passed away a few months after the use of the product. Cat #4 showed signs of ataxia, drooling, diarrhea, and vomiting a few hours after application. He was bathed, given some antibiotics, and given Kaopectate for the diarrhea that had developed. He is still not using the litter box but seems to have recovered. Cat #5 showed signs of ataxia and drooling a few hours after use of the product. He still has some ataxia, but caller noted that he broke one of his limbs as a kitten and had a cast on for a period of time. No new or worsening symptoms have presented. Cat #6 showed signs of hair loss, drooling, ataxia, and had some seizure like activity after use. The symptoms now seem to have resolved. Cat #7 showed sings of salivation, vomiting, ataxia, and became anorexic a few hours after use. The symptoms now seem to have resolved. The 2 dogs did not show any signs after the use of the product.

---

To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. This insecticide appears to be implicated in this case simply based on a temporal but coincidental product use scenario. Incident reportedly took place several months ago. Based on the known toxicological profile of the active ingredients used in this pesticide, when this product is used in the manner described in this incident, such significant adverse effects as reported are not expected. Furthermore, these animals were never properly evaluated and treated by a DVM, nor had a necropsy been performed to determine a cause of death. The cat's prior history regarding preventative medicine such as vaccinations, deworming and feline leukemia virus was not disclosed. All cats were described as having flea infestations which also must be considered as contributing factors in their clinical outcomes.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Siamese

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Salivating excessively

• Nervous and Muscular Systems
  • Symptom - Ataxia

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Not recovered / Non rétabli

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

11/19/2014 A report was forwarded for documentation. The report states that a consumer applied the product to her cats and dogs. The cats became ill, but the dogs remained asymptomatic. The cats developed respiratory problems, salivating, loss of balance, and vomiting. Consumer called back a week later, and reports that two of the cats died and one has still not recovered. She did not take the cats to a veterinarian, but did call the veterinarian. 11/21/2014 Call from the consumer. Caller used the product on 7 cats and 2 dogs several months ago. Cat #1 showed signs of ataxia, shortness of breath, drooling, and vomiting the next day after application. He did start to show signs of improvement but then passed away about 1 week after use. Caller noted that she bathed the cat but did not take him into a vet clinic. Cat #2 showed signs a few hours after application that progressively got worse until she passed away 2 days after application. The cat was showing signs of ataxia, shortness of breath, vomiting, and drooling. Cat #3 showed signs of ataxia, shortness of breath, vomiting, and drooling that started a few hours after use of the product. Caller syringe feed this cat, gave her subcutaneous fluids, and antibiotic injections, but did not seek veterinary care. She showed some improvement but then passed away a few months after the use of the product. Cat #4 showed signs of ataxia, drooling, diarrhea, and vomiting a few hours after application. He was bathed, given some antibiotics, and given Kaopectate for the diarrhea that had developed. He is still not using the litter box but seems to have recovered. Cat #5 showed signs of ataxia and drooling a few hours after use of the product. He still has some ataxia, but caller noted that he broke one of his limbs as a kitten and had a cast on for a period of time. No new or worsening symptoms have presented. Cat #6 showed signs of hair loss, drooling, ataxia, and had some seizure like activity after use. The symptoms now seem to have resolved. Cat #7 showed sings of salivation, vomiting, ataxia, and became anorexic a few hours after use. The symptoms now seem to have resolved. The 2 dogs did not show any signs after the use of the product.

---

To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. This insecticide appears to be implicated in this case simply based on a temporal but coincidental product use scenario. Incident reportedly took place several months ago. Based on the known toxicological profile of the active ingredients used in this pesticide, when this product is used in the manner described in this incident, such significant adverse effects as reported are not expected. Furthermore, these animals were never properly evaluated and treated by a DVM, nor had a necropsy been performed to determine a cause of death. The cat's prior history regarding preventative medicine such as vaccinations, deworming and feline leukemia virus was not disclosed. All cats were described as having flea infestations which also must be considered as contributing factors in their clinical outcomes.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

DSH

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Salivating excessively
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Ataxia
  • Symptom - Seizure

• Skin
  • Symptom - Hair loss

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

11/19/2014 A report was forwarded for documentation. The report states that a consumer applied the product to her cats and dogs. The cats became ill, but the dogs remained asymptomatic. The cats developed respiratory problems, salivating, loss of balance, and vomiting. Consumer called back a week later, and reports that two of the cats died and one has still not recovered. She did not take the cats to a veterinarian, but did call the veterinarian. 11/21/2014 Call from the consumer. Caller used the product on 7 cats and 2 dogs several months ago. Cat #1 showed signs of ataxia, shortness of breath, drooling, and vomiting the next day after application. He did start to show signs of improvement but then passed away about 1 week after use. Caller noted that she bathed the cat but did not take him into a vet clinic. Cat #2 showed signs a few hours after application that progressively got worse until she passed away 2 days after application. The cat was showing signs of ataxia, shortness of breath, vomiting, and drooling. Cat #3 showed signs of ataxia, shortness of breath, vomiting, and drooling that started a few hours after use of the product. Caller syringe feed this cat, gave her subcutaneous fluids, and antibiotic injections, but did not seek veterinary care. She showed some improvement but then passed away a few months after the use of the product. Cat #4 showed signs of ataxia, drooling, diarrhea, and vomiting a few hours after application. He was bathed, given some antibiotics, and given Kaopectate for the diarrhea that had developed. He is still not using the litter box but seems to have recovered. Cat #5 showed signs of ataxia and drooling a few hours after use of the product. He still has some ataxia, but caller noted that he broke one of his limbs as a kitten and had a cast on for a period of time. No new or worsening symptoms have presented. Cat #6 showed signs of hair loss, drooling, ataxia, and had some seizure like activity after use. The symptoms now seem to have resolved. Cat #7 showed sings of salivation, vomiting, ataxia, and became anorexic a few hours after use. The symptoms now seem to have resolved. The 2 dogs did not show any signs after the use of the product.

---

To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. This insecticide appears to be implicated in this case simply based on a temporal but coincidental product use scenario. Incident reportedly took place several months ago. Based on the known toxicological profile of the active ingredients used in this pesticide, when this product is used in the manner described in this incident, such significant adverse effects as reported are not expected. Furthermore, these animals were never properly evaluated and treated by a DVM, nor had a necropsy been performed to determine a cause of death. The cat's prior history regarding preventative medicine such as vaccinations, deworming and feline leukemia virus was not disclosed. All cats were described as having flea infestations which also must be considered as contributing factors in their clinical outcomes.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

DSH

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Anorexia
  • Symptom - Salivating excessively
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Ataxia

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

11/19/2014 A report was forwarded for documentation. The report states that a consumer applied the product to her cats and dogs. The cats became ill, but the dogs remained asymptomatic. The cats developed respiratory problems, salivating, loss of balance, and vomiting. Consumer called back a week later, and reports that two of the cats died and one has still not recovered. She did not take the cats to a veterinarian, but did call the veterinarian. 11/21/2014 Call from the consumer. Caller used the product on 7 cats and 2 dogs several months ago. Cat #1 showed signs of ataxia, shortness of breath, drooling, and vomiting the next day after application. He did start to show signs of improvement but then passed away about 1 week after use. Caller noted that she bathed the cat but did not take him into a vet clinic. Cat #2 showed signs a few hours after application that progressively got worse until she passed away 2 days after application. The cat was showing signs of ataxia, shortness of breath, vomiting, and drooling. Cat #3 showed signs of ataxia, shortness of breath, vomiting, and drooling that started a few hours after use of the product. Caller syringe feed this cat, gave her subcutaneous fluids, and antibiotic injections, but did not seek veterinary care. She showed some improvement but then passed away a few months after the use of the product. Cat #4 showed signs of ataxia, drooling, diarrhea, and vomiting a few hours after application. He was bathed, given some antibiotics, and given Kaopectate for the diarrhea that had developed. He is still not using the litter box but seems to have recovered. Cat #5 showed signs of ataxia and drooling a few hours after use of the product. He still has some ataxia, but caller noted that he broke one of his limbs as a kitten and had a cast on for a period of time. No new or worsening symptoms have presented. Cat #6 showed signs of hair loss, drooling, ataxia, and had some seizure like activity after use. The symptoms now seem to have resolved. Cat #7 showed sings of salivation, vomiting, ataxia, and became anorexic a few hours after use. The symptoms now seem to have resolved. The 2 dogs did not show any signs after the use of the product.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. This insecticide appears to be implicated in this case simply based on a temporal but coincidental product use scenario. Incident reportedly took place several months ago. Based on the known toxicological profile of the active ingredients used in this pesticide, when this product is used in the manner described in this incident, such significant adverse effects as reported are not expected. Furthermore, these animals were never properly evaluated and treated by a DVM, nor had a necropsy been performed to determine a cause of death. The cat's prior history regarding preventative medicine such as vaccinations, deworming and feline leukemia virus was not disclosed. All cats were described as having flea infestations which also must be considered as contributing factors in their clinical outcomes.