Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-0459

2. Registrant Information.

Registrant Reference Number: 070042306

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.

02-MAY-07

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

30-APR-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. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea And Tick Control For Dogs Under 14 kg

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

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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).

On April 30, 2007, at 10:07 am, CDT, the owner applied this product to her 11 month old, 16 pound, intact, male, Shih Tzu. The product was applied dermally to the animal as directed by the label. The owner was applying the product as a preventative measure.

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

Dog / Chien

3. Breed

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.91

7. Weight (provide a range if necessary )

16

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• General
  • Symptom - Abnormal behaviour

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 1, 2007 at 8:00 am, CDT the owner noted that the animal was anti social and was acting unusual 10 hours after the product was applied. The owner attempted to rinse off the animal's coat, on May 1, 2007 at 10:13 am, CDT, with water prior to contacting the APSS veterinarian. On May 2, 2007 at 10:06 am, CDT the owner called to report the exposure. The APSS veterinarian advised the owner to apply vitamin E topically to the application site and to monitor for dermatological signs.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here

A follow-up on this case was not deemed necessary, therefore the outcome is unknown.