Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-6111

2. Registrant Information.

Registrant Reference Number: 070065877

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Rd. 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.

27-JUN-07

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

26-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)

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

Product Name: Zodiac Fleatrol Flea and Tick Shampoo for Dogs and Cats

• Active Ingredient(s)
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration .5 %
  • PYRETHRINS
    • Guarantee/concentration .05 %

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7. b) Type of formulation.

Liquid

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 June 26, 2007, at 1:15 pm CDT, the owner bathed her male, neutered, 14 month old, Domestic Shorthair Cat with this product. The owner used this product per label instructions.

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

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.16

7. Weight (provide a range if necessary )

9

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Death

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 26,2007 at 3:00 pm, CDT, the owner went to check on the cat and found the cat had died. On June 26, 2007 at 4:00 pm, CDT the owner took the cat to her regular veterinarian. According to the owner her regular veterinarian performed a necropsy and found that the cat had an excessive subdural hemorrhage. The APSS veterinarian explained to the owner that the shampoo is not expected to cause neurologic signs-the concentration of pyrethrin in it is not high enough. The APSS veterinarian told the owner that they suspected the vet was confusing neurologic signs, such as tremors and seizures, with permethrin, which is a common ingredient in OTC (over the counter) dog flea treatments. This shampoo does not contain permethrin, and even concentrations of permethrin <1% are not expected to cause seizures. The APSS veterinarian also discussed with the owner that the sequence of events leading to the death also is not expected, even with permethrin toxicity-usually ataxia and tremors are seen first. The APSS veterinarian told the owner that they wouldn't expect a cat to die within 1.5-2hrs of exposure to a permethrin based product.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

APSS stated would not expect neurologic signs from pyrethrins with concentration less than 1%. Death of the animal is also not expected. The APSS veterinarian also recommended that a full necropsy (including histopathology and toxicology screening) be done to determine the cause of death in the cat. The owner declined. The APSS states the product have doubtful likelihood in causing the clinical situation.