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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-0476

2. Registrant Information.

Registrant Reference Number: 070063169

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.

21-JUN-07

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

21-JUN-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. 26496      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On Flea Control for Cats and Kittens

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Units: mL

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).

Around May 14, 2007 and approximately June 13, 2007, the owner applied 1 mL of the product to his 5 year old, neutered, male, Burmese mix cat. The exposure was used to prevent fleas, and the product was applied dermally. The use was appropriate.

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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Burmese mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

33.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>1 mo <=2 mos / > 1 mois < = 2 mois

11. List all symptoms

System

  • General
    • Symptom - Abnormal behaviour
    • Specify - Rolling
  • Skin
    • Symptom - Dermatitis

12. How long did the symptoms last?

Unknown / Inconnu

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

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Not recovered / Non 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 June 16, 2007 at approximately 12:00 p.m. CDT, the owner noticed the cat rolling and thought that the skin at the application site appeared swollen. The Animal Product Safety Service (APSS) staff noted that dermal hypersensitivity can occur with some exposures to this product and suggested the owner take the patient to the owner's regular veterinarian, have the veterinarian call for additional information, bathe the cat with liquid dish washing detergent, and provide the patient with symptomatic and supportive care.


To be determined by Registrant

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

Minor

19. Provide supplemental information here