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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-1163

2. Registrant Information.

Registrant Reference Number: 070125093

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G5L3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

29-NOV-07

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

29-NOV-07

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.

Product Name: Zodiac Flea And Tick Collar For Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 2.1 %
    • PROPOXUR
      • Guarantee/concentration 10 %

7. b) Type of formulation.

Other (specify)

Collar

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: collar

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).

On November 28, 2007 the owner applied the product to her cat as a form of treatment.

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

Medical Professional

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 )

0.12

7. Weight (provide a range if necessary )

1.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Respiratory System
    • Symptom - Dyspnea
  • General
    • Symptom - Death

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?

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

On November 29, 2007 the owner took the animal to the local veterinary clinic. The animal was examined by the attending veterinarian and was given fluid therapy and atropine. On November 29, 2007 the APSS staff member stated that the product has a wide margin of safety. The APSS staff member recommended that the attending veterinarian monitor the kitten's vital and respiratory signs and continue to supply symptomatic and supportive care to the animal. The owner stated that the kitten died shortly after the APSS consultation on November 29, 2007.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Inappropriate use. Minimum age on label is 12 weeks. The kitten was 6 weeks old. The owner declined a necropsy when it was suggested by the APSS staff member. According to APSS other causes cannot be ruled out.