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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-1588

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16000959

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.

10-APR-08

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

09-APR-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. 26491      PMRA Submission No.       EPA Registration No.

Product Name: Control Pet Care System One Spot Topical Treatment for Cats and Kitten

  • 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 it to her cat on 4/9/08.

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 )

6

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • General
    • Symptom - Vocalizing
  • Nervous and Muscular Systems
    • Symptom - Paralysis

12. How long did the symptoms last?

Anticip. permanent/Permanence anticipée

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?

Unknown

15. Outcome of the incident

Unknown/Inconnu

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

1-16000959: The reporter called on 4/10/08 to report her 6 year old female cat was paralyzed less than 24 hours after she had applied a topical flea and tick product containing the active ingredient Methoprene. She had applied the product to her cat the previous night, and noticed some funny meowing. The next morning the cat was paralyzed in its hind legs. The reporter had an appointment scheduled that day with her veterinarian, but wondered if there was anything she could do in the meantime. She was advised to try and wash the product off with tepid water and hand dish soap, and to take the cat into the veterinarian. Later that same day, the attending veterinarian called to discuss the safety profile of the product. She had diagnosed the cat with an aortic thromboembolism due to its classic clinical signs - bilateral hind leg paralysis, lack of femoral pulses, cold body temperature, pale mucous membranes, and pain. However, she wanted to verify that the symptoms could not be caused by the product. The safety profile of the product was discussed. The attending veterinarian was assured that paralysis or paresis was not part of the product's toxic syndrome, which would typically include ataxia, tremors, and seizures. A recommendation was made to perform an echocardiogram, and to try low-dose molecular weight heparin and cardiac medications as needed to treat the thromboembolism and manage any underlying cardiac disease. The reporter called back later in the day on 4/10/08 with a request for further information about the toxic profile of the product. Information regarding the typical toxicosis of the product was given. The reporter was also assured that paralysis was not part of the product's toxic syndrome, and was encouraged to work with her veterinarian looking into other differentials for the paralysis.


To be determined by Registrant

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

Major

19. Provide supplemental information here