Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-0551

2. Registrant Information.

Registrant Reference Number: 080139679

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.

15-DEC-08

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

15-DEC-08

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. 26413      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Double Action Flea Tick Shampoo

• Active Ingredient(s)
  • (S)-METHOPRENE
  • PIPERONYL BUTOXIDE
  • PYRETHRINS

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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 December 14, 2008, the owner inappropriately applied the product to her dogs that were too young.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

American Pit Bull Terrier/ Perro de Presa Canario Mix

4. Number of animals affected

8

5. Sex

Unknown

6. Age (provide a range if necessary )

0.12

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

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

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Seizure

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?

Treatment / Traitement

17. Provide any additional details about the incident

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

The APSS veterinarian stated that the shampoo would not cause seizures. The APSS veterinarian recommended that the owner put Karo Syrup on the pets' gums, take the pets to the veterinarian, and have the veterinarian call for information.

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To be determined by Registrant

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

Major

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not related to causing the clinical situation. Upon follow up, the owner stated she had brought the pets to the veterinarian, and that by December 16, 2008, the pets had fully recovered. It was also determined that the owner had docked the puppies' tails the same day the seizures occurred.