Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-5764

2. Registrant Information.

Registrant Reference Number: 080088913

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.

11-AUG-08

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

10-AUG-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

---

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: vial

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 August 10, 2008, the owner applied the product to their cat as a form of treatment.

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 )

7

7. Weight (provide a range if necessary )

13

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

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

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Shaking

• Respiratory System
  • Symptom - Heavy breathing

12. How long did the symptoms last?

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

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?

Treatment / Traitement

17. Provide any additional details about the incident

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

The owner took the cat to the emergency veterinarian. The veterinarian bathed the cat and administered methocarbamol. The Animal Product Safety Service (APSS) veterinarian stated that it is recommended for the emergency veterinarian to call so that the case could be discussed in more detail.

---

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 it is was doubtful that this substance was causing the clinical situation. Serious systemic effects would not be expected from the application of the product. The owner called and spoke with an APSS staff member to update the case. The owner wanted to know if she could send in an unused vial for batch testing, or if a hair test could be done. The owner has no dogs, but is aware that permethrin causes tremors and seizures in cats. An APSS veterinarian stated that the owner would need to have a DVM send in a hair sample for permethrin testing. The owner declined permethrin hair testing.