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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6150

2. Registrant Information.

Registrant Reference Number: 180128584

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G5L3

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

Domestic Animal

4. Date registrant was first informed of the incident.

30-JUL-18

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

20-JUL-18

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. Unknown

Product Name: Zodiac Cat Topical

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Units: mL

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).

On July 19, 2018, the owner applied an unknown size of this product to the five cats to treat a condition.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6.0

7. Weight (provide a range if necessary )

11.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Vocalizing
  • Gastrointestinal System
    • Symptom - Salivating excessively
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • Symptom - Death

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?

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

In the morning on July 20, 2018, the cat developed vocalization. Later in the afternoon that day, the cat developed hypersalivation and anorexia. Sometime in the morning on July 27, 2018, the cat developed seizures and died that afternoon. On July 30, 2018, the owner contacted the Animal Product Safety Service (APSS) whose veterinarian stated that this insecticide is safe to use on cats as a topical agent to treat fleas. The APSS veterinarian also stated that trembling and tremors can be seen, whereas seizure activity rarely occurs. The APSS veterinarian continued by stating that oral exposures often result in hypersalivation, nausea, and vomiting because of the taste and that some animals will hypersalivate just from the odor of the product. Finally, the APSS veterinarian stated that the signs displayed are not consistent with the reported product.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. A necropsy was unavailable, as the cat had already been buried.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Vocalizing
  • Gastrointestinal System
    • Symptom - Salivating excessively
    • Symptom - Anorexia
  • General
    • Symptom - Other
    • Specify - Abnormal Mucous Membrane Color
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • Symptom - Death

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?

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

In the morning on July 20, 2018, the cat developed vocalization. Later in the afternoon that day, the cat developed hypersalivation and anorexia. On July 21, 2018, the owner observed that the cat's mucous membrane color was black. Sometime in the morning on July 28, 2018, the cat developed seizures and died soon after. On July 30, 2018, the owner contacted the Animal Product Safety Service (APSS) whose veterinarian stated that this insecticide is safe to use on cats as a topical agent to treat fleas. The APSS veterinarian also stated that trembling and tremors can be seen, whereas seizure activity rarely occurs. The APSS veterinarian continued by stating that oral exposures often result in hypersalivation, nausea, and vomiting because of the taste and that some animals will hypersalivate just from the odor of the product. Finally, the APSS veterinarian stated that the signs displayed are not consistent with the reported product.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. A necropsy was unavailable, as the cat had already been buried.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7.0

7. Weight (provide a range if necessary )

18.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Vocalizing
  • Gastrointestinal System
    • Symptom - Salivating excessively
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • Symptom - Other
    • Specify - Abnormal Mucous Membrane Color
    • Symptom - Death

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?

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

In the morning on July 20, 2018, the cat developed vocalization. Later in the afternoon that day, the cat developed hypersalivation and anorexia. On July 21, 2018, the cat developed seizures and the owner observed that the cat's mucous membrane color was black. Soon after, the cat died. On July 30, 2018, the owner contacted the Animal Product Safety Service (APSS) whose veterinarian stated that this insecticide is safe to use on cats as a topical agent to treat fleas. The APSS veterinarian also stated that trembling and tremors can be seen, whereas seizure activity rarely occurs. The APSS veterinarian continued by stating that oral exposures often result in hypersalivation, nausea, and vomiting because of the taste and that some animals will hypersalivate just from the odor of the product. Finally, the APSS veterinarian stated that the signs displayed are not consistent with the reported product.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. A necropsy was unavailable, as the cat had already been buried.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7.0

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Vocalizing
  • Gastrointestinal System
    • Symptom - Salivating excessively
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • Symptom - Other
    • Specify - Abnormal Mucous Membrane Color
    • Symptom - Death

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?

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

In the morning on July 20, 2018, the cat developed vocalization. Later in the afternoon that day, the cat developed hypersalivation and anorexia. On July 21, 2018, the cat developed seizures and the owner observed that the cat's mucous membrane color was black. Soon after, the cat died. On July 30, 2018, the owner contacted the Animal Product Safety Service (APSS) whose veterinarian stated that this insecticide is safe to use on cats as a topical agent to treat fleas. The APSS veterinarian also stated that trembling and tremors ca be seen, whereas seizure activity rarely occurs. The APSS veterinarian continued by stating that oral exposures often result in hypersalivation, nausea, and vomiting because of the taste and that some animals will hypersalivate just from the odor of the product. Finally, the APSS veterinarian stated that the signs displayed are not consistent with the reported product.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. A necropsy was unavailable, as the cat had already been buried.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Russian Blue

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

8.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Vocalizing
  • Gastrointestinal System
    • Symptom - Salivating excessively
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • Symptom - Other
    • Specify - Abnormal Mucous Membrane Color
    • Symptom - Death

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?

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

In the morning on July 20, 2018, the cat developed vocalization. Later in the afternoon that day, the cat developed hypersalivation and anorexia. On July 22, 2018, the cat developed seizures and the owner observed that the cat's mucous membrane color was black. Soon after, the cat died. On July 30, 2018, the owner contacted the Animal Product Safety Service (APSS) whose veterinarian stated that this insecticide is safe to use on cats as a topical agent to treat fleas. The APSS veterinarian also stated that trembling and tremors can also be seen, whereas seizure activity rarely occurs. The APSS veterinarian continued by stating that oral exposures often result in hypersalivation, nausea, and vomiting because of the taste and that some animals will hypersalivate just from the odor of the product. Finally, the APSS veterinarian stated that the signs displayed are not consistent with the reported product.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. A necropsy was unavailable, as the cat had already been buried.