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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0082

2. Registrant Information.

Registrant Reference Number: 100058510

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.

10-MAY-10

5. Location of incident.

Country: CANADA

Prov / State: PRINCE EDWARD ISLAND

6. Date incident was first observed.

02-MAY-10

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. 28743      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On II 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.

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).

On May 2, 2010 the owner applied the product onto the cat.

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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

1

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

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Agitation
  • Skin
    • Symptom - Pruritus
    • Symptom - Dry skin
    • Specify - Dandruff

12. How long did the symptoms last?

Unknown / Inconnu

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

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 May 2, 2010 shortly after the product was applied, the cat became symptomatic. On May 10, 2010 the APSS veterinarian stated methoprene is an insect growth regulator and oral exposures may cause a taste reaction and possibly a dermal hypersensitivity reaction. The APSS veterinarian also stated that clinical signs are expected to be mild and self limiting and should not last for over a week, but it is possible the cat had the wrong product applied, or the cat is reacting to the fleas themselves. The APSS veterinarian recommended taking the cat to the veterinarian, a diagnostic evaluation, calling back with questions, and obtaining additional information on the product involved.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

On May 14, 2010 an APSS technician contacted the veterinary clinic to follow up on the case. The attending veterinarian stated the agitation and pruritus ended on May 10, 2010, but the cat was experiencing dandruff at the application site, at the time of the exam.