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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4230

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16300021

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.

19-JUN-08

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

18-JUN-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. 2596-147

Product Name: Control One Spot Flea and Tick Treatment for Cats (non-specific)

  • Active Ingredient(s)
    • (S)-METHOPRENE

7. b) Type of formulation.

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 his cat on 6/18/08. He had used the same product the previous 2 months with no problems.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • Symptom - Abnormal behaviour
    • Specify - Bit off 25% of tongue

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

Euthanised / Euthanasie

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

1-16300021: The reporter called on 6/19/08 to report his cat had developed seizures after the application of a topical flea and tick product containing the active ingredient Methoprene. According to the reporter, he had applied the product on 6/18 and within 60 minutes the cat had developed seizures. By the time of the call, the cat had had 6 seizures during the night and had bitten off 25% of her tongue. The reporter stated that he had spoken to several (2) veterinarians over the phone who had recommended euthanasia. It was discussed that seizures would not be an expected reaction to the product and a recommendation was made that the cat should be evaluated by a veterinarian. The company sponsored hair testing and necropsy programs were discussed. A follow-up call on 6/20 revealed the cat had had 5-6 additional seizures since the reporter┐s initial phone call. He had euthanized her the morning of 6/20. The company sponsored necropsy program was again discussed, but the reporter declined as he had already buried her. Note: the reporter stated he had used the same product the previous 2 months with no problems.


To be determined by Registrant

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

Major

19. Provide supplemental information here