Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-1852

2. Registrant Information.

Registrant Reference Number: 2012CA00413

Registrant Name (Full Legal Name no abbreviations): Merck Animal Health (Intervet Canada Corp)

Address: 16750 Transcanada Highway

City: Kirkland

Prov / State: Quebec

Country: Canada

Postal Code: H9H 4M7

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

02-MAY-12

5. Location of incident.

Country: CANADA

Prov / State: SASKATCHEWAN

6. Date incident was first observed.

02-MAY-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. 22968      PMRA Submission No.       EPA Registration No.

Product Name: Defend

• Active Ingredient(s)
  • PERMETHRIN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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).

Adverse event reaction reported by the poison control center. The pet owner applied an unknown amount of Defend dermally on a cat. The exposure occurred at the animal owner's home on 02 May 2012. The owner used the product in an off-label (not specie appropriate) manner on the cat this morning. The cat was presented to the clinic with convulsive activity in the evening .The attending vet has stabilized the cat thus far with supportive care. The case is ongoing. Update 09 May 2012, the cat was kept on fluids overnight on the 02 May 2012. She has been doing well since but is still staggering. The attending vet expects her to make a full recovery. The case is closed.

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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic short hair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

10.00

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Convulsions
  • Symptom - Ataxia

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?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

15. Outcome of the incident

Recvrd resid.effects/Rétabli séquelles

16. How was the animal exposed?

Other / Autre

specify The pet owner used the product on the cat even though it is not indicated for this specie.

17. Provide any additional details about the incident

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

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To be determined by Registrant

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

Major

19. Provide supplemental information here