Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-5816

2. Registrant Information.

Registrant Reference Number: 080057441

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.

30-MAY-08

5. Location of incident.

Country: CANADA

Prov / State: NEW BRUNSWICK

6. Date incident was first observed.

29-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)

---

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

---

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

---

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 29, 2008, the owner applied 1 mL of the Zodiac Spot On Flea Control to her cat as a preventative measure. On the same day, the cat was exposed to a dog in the home that was treated with the Zodiac Fleatrol Power Spot Flea And Tick Control.

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

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6.5

7. Weight (provide a range if necessary )

6

lbs

8. Route(s) of exposure

Skin

Unknown

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 - Muscle tremors

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Contact treat.area/Contact surf. traitée

specify Treatment and Relay Exposure to Treated Dog

17. Provide any additional details about the incident

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

On May 30, 2008, the owner took the animal to the local veterinary clinic where she was monitored and given fluid therapy and a muscle relaxer. On the same day, the APSS veterinary staff stated that the exposure to S-methoprene may lead to mild gastrointestinal upset a and a taste reaction. Exposure to permethrin can lead to tremors, seizures, and death.

---

To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS veterinarian stated that the exposure to the cat product was not related to the clinical situation. Inappropriate use. Label states cats that actively groom or engage in close physical contact with recently treated dogs may be at risk of harm.