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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0028

2. Registrant Information.

Registrant Reference Number: 2013-US-08997

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.

22-OCT-13

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

07-OCT-13

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

Product Name: ACTIVYL TICK PLUS

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

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

4

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).

Suspected Adverse Reaction; On 22 Oct 2013, a manager reported a suspected adverse reaction with Activyl Tick Plus for Dogs and Puppies (over 44 lb and up to 88 lb) in dog. The product was applied at 3 spots on the back on approximately 06 Oct 2013 and fur loss was noted at the sites of application on 07 Oct 2013. The product had been applied in Aug and Sep 2013 without incident. The dog had been diagnosed with lupus in 2012 and was euthanized because of the disease on 22 Oct 2013. A necropsy was not performed. The product was purchased at the veterinary clinic. No more information is expected.

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

Dog / Chien

3. Breed

Terrier large breed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8.5

7. Weight (provide a range if necessary )

45.0

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

  • Skin
    • Symptom - Hair loss

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?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Euthanised / Euthanasie

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

Suspected Adverse Reaction; On 22 Oct 2013, a manager reported a suspected adverse reaction with Activyl Tick Plus for Dogs and Puppies (over 44 lb and up to 88 lb) in dog. The product was applied at 3 spots on the back on approximately 06 Oct 2013 and fur loss was noted at the sites of application on 07 Oct 2013. The product had been applied in Aug and Sep 2013 without incident. The dog had been diagnosed with lupus in 2012 and was euthanized because of the disease on 22 Oct 2013. A necropsy was not performed. The product was purchased at the veterinary clinic. No more information is expected.


To be determined by Registrant

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

Death

19. Provide supplemental information here