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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-0162

2. Registrant Information.

Registrant Reference Number: 090094017

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.

20-AUG-09

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

20-AUG-09

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. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea and Tick Control for Dogs Over 14 kg

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

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 August 19, 2009 the pet owner applied the product to dogs in the household. The owner suspects that the cat was accidentally exposed to the product by socializing with the dogs.

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

Himalayan

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

15

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Muscle tremors

12. How long did the symptoms last?

>2 hrs <=8 hrs / > 2 h < = 8 h

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

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Other / Autre

specify Contact with a treated animal

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

The APSS veterinarian recommended that the pet owner take the cat to the veterinarian and have the veterinarian call for information. The veterinarian contacted the APSS later that same day. The APSS veterinarian recommended that the regular veterinarian manage tremors with methocarbamol, bathe the cat with liquid dish soap, keep the cat warm after bathing, and call back with questions.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

On September 1, 2009 the patient record was received from the attending veterinarian by the APSS technician. Per the patient record, the cat was treated with methocarbamol, bathed, kept warm, and was given subcutaneous fluids. The cat's tremors had changed from severe to mild on the evening of August 20, 2009. The cat was discharged that same evening to the owner with instructions for the owner to give methocarbamol at home if needed for tremors. On September 2, 2009 the pet owner spoke with an APSS assistant and stated that the cat made a full recovery on August 20, 2009. The product was not used according to label directions: Cats that actively groom or engage in close physical contact with recently treated dog may be at risk of harm.