Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0082

2. Registrant Information.

Registrant Reference Number: 120049589

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.

19-APR-12

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

18-APR-12

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. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot 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 April 16, 2012 the owner inapropriately applied the product to her cat to prevent fleas.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Feline Domestic Unspecified

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7.0

7. Weight (provide a range if necessary )

20.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Hiding

• Nervous and Muscular Systems
  • Symptom - Aggressive behaviour

• General
  • Symptom - Abnormal behaviour
  • Specify - Anti Social Behavior

12. How long did the symptoms last?

Unknown / Inconnu

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

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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 April 18, 2012 the owner noticed that the cat was symptomatic. On April 19, 2012 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that cats do not tolerate permethrin and that there are individual variations in sensitivity; some cats are sensitive enough that even casual contact with a treated dog could cause clinical signs. The APSS veterinarian also stated that signs range from mild dermal hypersensitivity to seizures and that signs could develop from almost immediately up to 72 hours after an exposure to the product. The APSS veterinarian said that dermal hypersensitivity could cause changes like aggression, but these changes should be mild and self-limiting. The APSS veterinarian further stated that if no tremors or seizures develop within 72 hours, they would not be expected to occur. The APSS assistant recommended that the owner bathe the cat with liquid dish washing detergent (LDWD), apply vitamin E to the cat, monitor the cat at home, 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

Signs were expected to be mild and self-limiting.