Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-6046

2. Registrant Information.

Registrant Reference Number: 080045924

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.

02-MAY-08

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

02-MAY-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. 26496      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On Flea Control For Cats And Kittens

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

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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

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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 May 1, 2008, the owner applied the Zodiac Spot On Flea Control For Cats And Kittens. The cat came into contact with the Zodiac Fleatrol Power Spot Flea and Tick Control on May 1, 2008 from laying on a treated animal's bedding.

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 )

12

7. Weight (provide a range if necessary )

14

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Skin
  • Symptom - Hair loss

• Nervous and Muscular Systems
  • Symptom - Trembling
  • Symptom - Agitation

• Skin
  • Symptom - Dermatitis
  • Symptom - Erythema

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Contact treat.area/Contact surf. traitée

17. Provide any additional details about the incident

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

On May 2, 2008, the APSS technician recommended that the owner bathe the cat, monitor him for dermatological signs and tremors, and call back with any questions. The owner called the APSS back after bathing the cat and stated that the cat's tremors had increased in intensity. The APSS veterinarian then recommended that the owner take the cat to her local veterinary clinic and have the attending veterinarian call for further information. The owner said she took her pet to the DVM on May 3. The DVM treated with an unknown injection, and the pet made a full recovery by the following morning, May 4, 2008.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS certified veterinary technician stated that the cat product was not likely to cause the clinical situation, where as, the dog product was considered to have a high likelihood of causing the clinical situation. Inappropriate use. Label states that cats that actively groom or engage in close physical contact with recently treated dogs may be at risk of harm.