Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-4548

2. Registrant Information.

Registrant Reference Number: ProPharma Group case:# 1-44847617

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.

14-JUL-16

5. Location of incident.

Country: UNITED STATES

Prov / State: KENTUCKY

6. Date incident was first observed.

03-JUL-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. 2596-140

Product Name: HARTZ ULTRA GUARD PLUS FLEA & TICK SPRAY FOR DOGS

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .07 %
  • TETRACHLORVINPHOS
    • Guarantee/concentration 1.08 %

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7. b) Type of formulation.

Other (specify)

Spray

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

Toy Poodle

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

3.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Seizure
  • Symptom - Muscle weakness
  • Symptom - Coma

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?

Yes

14. b) How long was the animal hospitalized?

10

Day(s) / Jour(s)

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

1-44847617 - The reporter, a pet owner, indicated her dog was exposed to an insecticidal spray containing the active ingredients (S)-methoprene and tetrachlorvinphos. Fourteen days before initial contact with the registrant, the reporter sprayed the product on her 3.5-pound, 3-year-old, female, Toy Poodle dog. Eleven days before initial contact, the dog developed seizures so the reporter took her into the veterinarian where she was treated then hospitalized for three days. The dog appeared to be better other than some muscle weakness, so the reporter took her home. Eight days before the initial contact with the registrant, the dog started having seizures again at home, and the dog was taken to the veterinarian the next day where the dog continued to have seizures and eventually fell into a coma. The dog remained hospitalized until the day of initial contact with the registrant when she died at the clinic. Condolences were offered to the registrant. The dogs remains were submitted for necropsy (animal autopsy), but results have not been received at the time of submission of this report. 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