Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0101

2. Registrant Information.

Registrant Reference Number: 110154270

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.

05-DEC-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

03-DEC-11

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. 28743      PMRA Submission No.       EPA Registration No.

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

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

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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 December 3, 2011 the owner applied the product to the cat to prevent fleas.

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

Medical Professional

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 )

8.0

7. Weight (provide a range if necessary )

5.3

kg

8. Route(s) of exposure

Skin

Oral

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

• Gastrointestinal System
  • Symptom - Drooling

• Eye
  • Symptom - Pupil dilation

12. How long did the symptoms last?

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

On December 3, 2011 the owner noticed that the cat had tremors, was symptomatic. Later that evening, the owner bathed the cat and then took the cat to the veterinarian, where Methocarbamol was given rectally. The owner declined fluids for the cat. Later that evening, the cat had fully recovered. On December 5, 2011 the regular veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that Methoprene is an insect growth regulator that would not be expected to cause tremors and that the possibility that the cat was exposed to permethrins should be considered. The APSS veterinarian recommended that the regular veterinarian have permethrin hair testing done and call back with questions.

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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 veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On December 7, 2011 an APSS technician called the regular veterinarian to discuss permethrin hair testing. The regular veterinarian declined the hair testing. Advised that owner used pyrethrin based flea control for dogsand that dog and cat were together.