Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-4693

2. Registrant Information.

Registrant Reference Number: 2015-US-10852

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.

29-AUG-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

29-AUG-15

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.       PMRA Submission No.       EPA Registration No. 773-95

Product Name: ACTIVYL TICK PLUS

• Active Ingredient(s)
  • INDOXACARB TECHNICAL
  • PERMETHRIN
    • Guarantee/concentration 42.5 %

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7. b) Type of formulation.

Liquid

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).

Suspected Adverse Reaction: On 29 Aug 2015, a pet owner reported to the ASPCA Animal Poison Control Center that his dog had a reaction to an unknown Activyl product, possibly Activyl Tick Plus for Small Dogs 11-22 pounds. The product had been obtained through a veterinarian. The product was applied on 29 Aug 2015 and 45 minutes after application, the dog had a behavioral change, was laying down, staring and acting "stoned" and the pet owner felt that the dog was severely lethargic and close to dying. The dog was bathed and the pet owner planned to take the dog to a veterinarian for care. Follow up pending by ASPCA Animal Poison Control Center.Follow up 02 Sep 2015, the pet owner had reported to the ASPCA Animal Poison Control Center that the dog had passed away on 29 Aug 2015. A necropsy has not been performed. No more information is expected.

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

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5.5

7. Weight (provide a range if necessary )

15.00

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

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Bizarre behaviour
  • Symptom - Recumbent

• General
  • Symptom - Lethargy

• Eye
  • Symptom - Other
  • Specify - staring

12. How long did the symptoms last?

Persisted until death

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

No

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

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

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To be determined by Registrant

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

Death

19. Provide supplemental information here