Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-3433

2. Registrant Information.

Registrant Reference Number: 2020-US-013650, 013649, 013652, 013654, 013655

Registrant Name (Full Legal Name no abbreviations): The Hartz Mountain Corporation

Address: 400 Plaza Drive

City: Secaucus

Prov / State: New Jersey

Country: USA

Postal Code: 07094-3688

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

Domestic Animal

4. Date registrant was first informed of the incident.

24-MAY-20

5. Location of incident.

Country: UNITED STATES

Prov / State: GEORGIA

6. Date incident was first observed.

19-MAY-20

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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2596-153

Product Name: Hartz UltraGuard Rid Flea and Tick Shampoo for Dogs 18oz

• Active Ingredient(s)
  • D-PHENOTHRIN
    • Guarantee/concentration .27 %

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7. b) Type of formulation.

Liquid

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?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Pit Bull and German Shepherd crossbred

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.23

7. Weight (provide a range if necessary )

10

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

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Anorexia
  • Symptom - Vomiting
  • Symptom - Foaming at mouth

• General
  • Symptom - Dehydration
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Yes

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

On 19-May-2020, a 12 week old, approximately 10 pound, intact, female, Pit Bull/German Shepherd crossbred dog, in unknown condition, with no known concomitant medical condition, was administered 1 application of Hartz UltraGuard Rid Flea and Tick Shampoo for Dogs 18oz (Phenothrin (Sumithrin)) via the topical route by the animal owner. This was an extra label use as the product is not labeled for use on dogs under 6 months of age. On approximately 20-May-2020, the dog exhibited anorexia, vomiting and foaming at the mouth. The dog was evaluated by a veterinarian and was reported to be dehydrated and underweight. The dog tested negative for parvovirus, was administered intravenous fluids, another unspecified medication and was sent home with instructions for feeding and monitoring. On 21-May-2020, the dog died at home. It is unknown if a necropsy was performed. The same product was also applied to four other puppies from the same litter and their mother, all within a few days of each other. All five exposed puppies died within one to three days of product application (see other Domestic Animal subforms). Their mother developed lethargy, adipsia, anorexia, vomiting and hiding one day post administration (coded as moderate severity). The clinical signs continued after the mother dog was bathed 3 times with liquid degreasing dish detergent. One puppy that did not have the product applied to it remained asymptomatic. No further information was received.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

Assessment: The active ingredient in this product is present in low concentration and has a wide margin of safety in dogs. Although the product was misused in this case as the puppy was below the labeled minimum age, severe GI signs and death are not expected. Mild GI upset may occur if the product is ingested but is generally self-limited. Other causes including infectious diseases (viral, bacterial, parasites), congenital defects, malnourishment, and other exposures should be considered. 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.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Pit Bull and German Shepherd crossbred

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.23

7. Weight (provide a range if necessary )

10

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

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Anorexia
  • Symptom - Vomiting
  • Symptom - Foaming at mouth
  • Symptom - Weight loss

• 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

On 18-May-2020, a 12 week old, approximately 10 pound, intact, male, Pit Bull/German Shepherd crossbred dog, in unknown condition, with no known concomitant medical conditions, was administered 1 application of Hartz UltraGuard Rid Flea and Tick Shampoo for Dogs 18oz (Phenothrin (Sumithrin)) via the topical route by the animal owner. This was an extra label use as the product is not labeled for use on dogs under 6 months of age. On 19-May-2020, the dog exhibited weight loss, anorexia, vomiting, foaming at the mouth, and died later that night. The dog was not evaluated by a veterinarian and no treatments were performed. It is unknown if a necropsy was performed. The same product was also applied to four other puppies from the same litter and their mother, all within a few days of each other. All five exposed puppies died within one to three days of product application (see other Domestic Animal subforms). Their mother developed lethargy, adipsia, anorexia, vomiting and hiding one day post administration (coded as moderate severity). The clinical signs continued after the mother dog was bathed 3 times with liquid degreasing dish detergent. One puppy that did not have the product applied to it remained asymptomatic. No further information was received.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

Assessment: The active ingredient in this product is present in low concentration and has a wide margin of safety in dogs. Although the product was misused in this case as the puppy was below the labeled minimum age, severe GI signs and death are not expected. Mild GI upset may occur if the product is ingested but is generally self-limited. Other causes including infectious diseases (viral, bacterial, parasites), congenital defects, malnourishment, and other exposures should be considered. 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.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Pit Bull and German Shepherd crossbred

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.23

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• 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

On 21-May-2020 and 23-May-2020, a 12 week old, approximately 10 pound, intact, male, Pit Bull/German Shepherd crossbred dog, in unknown condition, with no known concomitant medical conditions, was administered 1 application of Hartz UltraGuard Rid Flea and Tick Shampoo for Dogs 18oz (Phenothrin (Sumithrin)) via the topical route by the animal owner. This is an extra label use as the product is not labeled for use on dogs under 6 months of age. Approximately 8 hours post administration on 23-May-2020, the dog died. The dog was not evaluated by a veterinarian and no treatments were performed. It is unknown if a necropsy was performed. The same product was also applied to four other puppies from the same litter and their mother, all within a few days of each other. All five exposed puppies died within one to three days of product application (see other Domestic Animal subforms). Their mother developed lethargy, adipsia, anorexia, vomiting and hiding one day post administration (coded as moderate severity). The clinical signs continued after the mother dog was bathed 3 times with liquid degreasing dish detergent. One puppy that did not have the product applied to it remained asymptomatic. No further information was received.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here

Assessment: The active ingredient in this product is present in low concentration and has a wide margin of safety in dogs. Although the product was misused in this case as the puppy was below the labeled minimum age, sudden death is not expected. Mild GI upset may occur if the product is ingested but is generally self-limited. Other causes including infectious diseases (viral, bacterial, parasites), congenital defects, malnourishment, and other exposures should be considered. 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.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Pit Bull and German Shepherd crossbred

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.23

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• 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

On 21-May-2020 and 23-May-2020, a 12 week old, approximately 10 pound, intact, female, Pit Bull/Shepherd Dog - German crossbred dog, in unknown condition, with no known concomitant medical conditions, was administered 1 application of Hartz UltraGuard Rid Flea and Tick Shampoo for Dogs 18oz (Phenothrin (Sumithrin)) via the topical route by the animal owner. This was an extra label use as the product is not labeled for use on dogs under 6 months of age. Approximately 8 hours post administration on 23-May-2020, the dog died. The dog was not evaluated by a veterinarian and no treatments were performed. It is unknown if a necropsy was performed. The same product was also applied to four other puppies from the same litter and their mother, all within a few days of each other. All five exposed puppies died within one to three days of product application (see other Domestic Animal subforms). Their mother developed lethargy, adipsia, anorexia, vomiting and hiding one day post administration (coded as moderate severity). The clinical signs continued after the mother dog was bathed 3 times with liquid degreasing dish detergent. One puppy that did not have the product applied to it remained asymptomatic. No further information was received.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here

Assessment: The active ingredient in this product is present in low concentration and has a wide margin of safety in dogs. Although the product was misused in this case as the puppy was below the labeled minimum age, sudden death is not expected. Mild GI upset may occur if the product is ingested but is generally self-limited. Other causes including infectious diseases (viral, bacterial, parasites), congenital defects, malnourishment, and other exposures should be considered. 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.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Pit Bull and German Shepherd crossbred

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.23

7. Weight (provide a range if necessary )

10

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

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Foaming at mouth

• Nervous and Muscular Systems
  • Symptom - Ataxia

• General
  • Symptom - Lethargy
  • Symptom - Weakness
  • 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

On 23-May-2020, a 12 week old, approximately 10 pound, intact, female, Pit Bull/German Shepherd crossbred dog, in unknown condition, with no known concomitant medical conditions, was administered 1 application of Hartz UltraGuard Rid Flea and Tick Shampoo for Dogs 18oz (Phenothrin (Sumithrin)) via the topical route by the animal tender. This was an extra label use as the product is not labeled for use on dogs under 6 months of age. On approximately 24-May-2020, the dog exhibited lethargy, foaming at the mouth and appeared to have difficulty using her hind legs (ataxia). The dog became progressively more weak until it could not stand to urinate or defecate. On 25-May-2020, the dog died and was then buried. The dog was not evaluated by a veterinarian and no treatments were performed. The same product was also applied to four other puppies from the same litter and their mother, all within a few days of each other. All five exposed puppies died within one to three days of product application (see other Domestic Animal subforms). Their mother developed lethargy, adipsia, anorexia, vomiting and hiding one day post administration (coded as moderate severity). The clinical signs continued after the mother dog was bathed 3 times with liquid degreasing dish detergent. One puppy that did not have the product applied to it remained asymptomatic. No further information was received.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here

Assessment: The active ingredient in this product is present in low concentration and has a wide margin of safety in dogs. Although the product was misused in this case as the puppy was below the labeled minimum age, severe anorexia, lethargy, weakness, and death is not expected. Mild GI upset may occur if the product is ingested but is generally self-limited. Other causes including infectious diseases (viral, bacterial, parasites), congenital defects, malnourishment, and other exposures should be considered. 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.