Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7187

2. Registrant Information.

Registrant Reference Number: 130051371

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.

22-APR-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

20-APR-13

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)

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PMRA Registration No. 28598      PMRA Submission No.       EPA Registration No.

Product Name: Vet Kem Ovitrol Dual Action Collar For Cats And Kittens

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

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7. b) Type of formulation.

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 April 20, 2013 the owner placed the collar on the cat to prevent fleas.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

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

Male

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

6.80

kg

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

• General
  • Symptom - Licking
  • Specify - Licking Lips

• Skin
  • Symptom - Dermatitis

12. How long did the symptoms last?

<=30 min / <=30 min

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

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 April 20, 2013 the owner observed that the cat was symptomatic, the signs resolved soon after the owner removed the collar from the cat. The next day, April 21, 2013, the owner placed the collar back on the cat, and the cat began licking his lips again for a short time; once again, the signs resolved shortly after the owner removed the collar from the cat and the cat remained asymptomatic since that time. On April 22, 2013 the owner's regular veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that most likely the cat was able to lick the collar, resulting in a taste reaction; it was also possible that the cat was bothered by the odor of the collar. The APSS veterinarian said that no significant signs would be expected, and no treatment was indicated at that time. The APSS veterinarian recommended that the owner's regular veterinarian call back with questions.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here

Signs expected to be mild and self limiting