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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-3204

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16221634

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.

02-JUN-08

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

30-MAY-08

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. 2596-151

Product Name: Advanced Care 3 in 1 Once A Month Flea and Tick Drops for Dogs 16-30 l

  • Active Ingredient(s)
    • D-PHENOTHRIN
      • Guarantee/concentration 85,7 %

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).

The reporter applied the product to her dog on 5/3008. The product was used against label directions - it was designed for dogs 16-30 lbs. The reporter's dog weighed 12 lbs.

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

Pomeranian

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5

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

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Extensor rigidity
    • Specify - Falling over on his back with his legs straight out and would not move
  • General
    • Symptom - Adipsia
    • Specify - Would not drink water
    • 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

1-16221634: The reporter called on 6/2/08 to report her 5 year dog had passed away 2 days after she had applied a topical flea and tick product containing the active ingredient Permethrin. According to the reporter, she had applied the product on 5/30/08. That evening the dog had refused to drink any water. He had also begun falling over onto his back with his legs straight out and then would not move. She tried but was unable to contact the registrant on 5/30. The reporter bathed the dog the next day (5/31) and had planned to take him to a veterinarian on 6/2 (she could not afford emergency weekend veterinary care). The reporter stated the dog had passed away the evening of 6/1. Sudden death was discussed as an unexpected reaction to the product. The company sponsored necropsy program was offered but the reporter declined.


To be determined by Registrant

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

Death

19. Provide supplemental information here