Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-5620

2. Registrant Information.

Registrant Reference Number: ProPharma Group case:# 1-45092058

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.

03-AUG-16

5. Location of incident.

Country: UNITED STATES

Prov / State: INDIANA

6. Date incident was first observed.

01-AUG-16

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. 2596-167

Product Name: HARTZ ULTRAGUARD TOPICAL FLEA&TICK PREV. FOR DOGS&PUPPIES 31-60 LBS

• Active Ingredient(s)
  • ETOFENPROX
    • Guarantee/concentration 55 %
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • Guarantee/concentration 1 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 10 %

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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).

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

Dog / Chien

3. Breed

Irish Setter

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

51

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
  • Symptom - Lethargy

• Nervous and Muscular Systems
  • Symptom - Difficulty getting up

• Renal System
  • Symptom - Renal failure

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?

Unknown

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

1-45092058 - The reporter, a pet owner, indicated his dog was exposed to an insecticidal spot-on product containing the active ingredients piperonyl butoxide, etofenprox, and N-octyl bicycloheptene dicarboximide. Four days before initial contact with the registrant, the reporter applied the product to his 51-pound, 8-year-old, female, Irish Setter dog. Two days before initial contact, the reporter noticed the dog became lethargic. One day before initial contact, the dog had difficulty getting up and the reporter brought her to the veterinarian. The dog was diagnosed with kidney dysfunction and placed on intravenous fluids. The reporter was advised that this is not an expected reaction to the product and recommended the veterinarian rule out other causes as well as treat the symptoms. On follow-up call two days later, the reporter indicated the dog had died at the veterinary clinic as her kidneys had failed. Condolences were offered as well as a necropsy, but the dog had already been cremated. No additional information is available.

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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