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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-3636

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16064309

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.

24-APR-08

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

23-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/Kittens

  • 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 the cat on 4/23/08.

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

Unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

10

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 / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Agitation
  • Skin
    • Symptom - Itchy skin
    • Specify - Scratching at skin where product had been applied
  • Eye
    • Symptom - Pupil dilation
  • Respiratory System
    • Symptom - Panting
  • Gastrointestinal System
    • Symptom - Inappropriate defecation
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • Respiratory System
    • Symptom - Heavy breathing

12. How long did the symptoms last?

Unknown / Inconnu

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

1-16064309: The reporter called on 4/24/08 to report her 4 year old female cat had developed symptoms after the reporter had applied a topical flea and tick product containing the active ingredient Methoprene the previous day (4/23). Immediately after application of the product, the cat had become agitated, and had run around scratching at the application site. About 45 minutes after application, the cat had begun panting and her pupils had dilated. As the reporter tried to wash the product off, the cat soiled herself with feces. The reporter took the cat into a veterinarian that same day for evaluation. At the veterinary clinic, the cat had a seizure, was bathed again, was "gassed" and had "her stomach pumped", and was given fluids. The cat was monitored at the clinic but was not placed on any medications. At the time of the call, the cat was home but the owner stated her breathing was intermittently heavy. The attending veterinarian believed the cat had had an allergic reaction to the product, and had instructed the owner to monitor the cat's breathing and bring her back in if it worsened. The safety profile of the product was discussed as well as the possibility of individual sensitivities or idiosyncratic reactions. Several attempts were made at follow-up; contact with the reporter was re-established on 4/28/08. At that time, the cat's breathing problems had continued but were improving.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here