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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-0194

2. Registrant Information.

Registrant Reference Number: ProPharma Group case#: 1-54896834

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.

05-DEC-18

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

27-NOV-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. 2596-165

Product Name: HARTZ PET DEFENDER PLUS FOR DOGS (45-88 LBS)

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 8,8 %

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).

1-54896834 - The product is not intended for use in cats nor for dogs weighing less than 45 pounds.

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

Cat / Chat

3. Breed

Domestic Shorthair

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

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

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Vomiting
    • Symptom - Diarrhea

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

1-54896834 - The reporter, a pet owner, indicates an exposure to pesticide spot-on product containing the active ingredients (S)-methoprene and fipronil. Ten days before the day of initial contact with the registrant, the reporter applied the product to her 3-year-old, female, domestic shorthair cat of unknown weight. An unknown amount of time later, the cat developed anorexia, vomiting and diarrhea. Eight days before the day of initial contact, the cat died before the reporter could seek veterinary care. The reporter was advised this is not an expected reaction to normal product use. No additional information is available.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Rottweiler

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.83

7. Weight (provide a range if necessary )

60

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Vomiting
  • General
    • Symptom - Lethargy

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

1-54896834 - The reporter, a pet owner, indicates an exposure to pesticide spot-on product containing the active ingredients (S)-methoprene and fipronil. Ten days before the day of initial contact with the registrant, the reporter applied the product to her 10-month-old, 60-pound, male, Rottweiler dog. An unknown amount of time later, the dog developed anorexia, vomiting and lethargy. Eight days before the day of initial contact, the dog died before the reporter could seek veterinary care. The reporter was advised this is not an expected reaction to normal product use. No additional information is available.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Mixed

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 )

12

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Vomiting
  • General
    • Symptom - Lethargy

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

1-54896834 - The reporter, a pet owner, indicates an exposure to pesticide spot-on product containing the active ingredients (S)-methoprene and fipronil. Ten days before the day of initial contact with the registrant, the reporter applied the product to her 12-week-old, 12-pound, male, mixed breed dog. An unknown amount of time later, the dog developed anorexia, vomiting and lethargy. Eight days before the day of initial contact, the dog died before the reporter could seek veterinary care. The reporter was advised this is not an expected reaction to normal product use. No additional information is available.


To be determined by Registrant

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

Death

19. Provide supplemental information here