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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3450

2. Registrant Information.

Registrant Reference Number: 2013-US-04799

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.

11-JUN-13

5. Location of incident.

Country: UNITED STATES

Prov / State: KENTUCKY

6. Date incident was first observed.

11-APR-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.

2

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 event and suspected lack of expected efficacy. Suspected adverse event: On 11 Jun 2013 a veterinarian reported that a dog developed a localized reaction (moist dermatitis) at the site of application following application of Activyl TickPlus for Dogs and Puppies (over 11 lbs and up to 22 lbs). The product was applied on 26 Mar 2013 and the reaction was noticed on 11 Apr 2013. The dog received unknown treatment at home from the owners. On approximately 28 Apr 2013 the dog developed pancreatitis and was euthanized due to the pancreatitis on 24 May 2013. Suspected lack of expected efficacy: On 11 Jun 2013 a vet reported that a dog still had fleas following treatment with Activyl TickPlus for Dogs and Puppies (over 11 lbs and up to 22 lbs). The product was applied on 26 Mar 2013 and the fleas were noticed on 11 Apr 2013. The vet is unsure if the home was infested, if other animals were in the home, or if the dog was bathed. The product was obtained from the veterinary clinic. The vet did not have lot numbers. No further 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

Shipperke

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

13.00

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

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • Skin
    • Symptom - Dermatitis
  • Gastrointestinal System
    • Symptom - Other
    • Specify - Pancreatitis

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

Unknown

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 event and suspected lack of expected efficacy. Suspected adverse event: On 11 Jun 2013 a veterinarian reported that a dog developed a localized reaction (moist dermatitis) at the site of application following application of Activyl TickPlus for Dogs and Puppies (over 11 lbs and up to 22 lbs). The product was applied on 26 Mar 2013 and the reaction was noticed on 11 Apr 2013. The dog received unknown treatment at home from the owners. On approximately 28 Apr 2013 the dog developed pancreatitis and was euthanized due to the pancreatitis on 24 May 2013. Suspected lack of expected efficacy: On 11 Jun 2013 a vet reported that a dog still had fleas following treatment with Activyl TickPlus for Dogs and Puppies (over 11 lbs and up to 22 lbs). The product was applied on 26 Mar 2013 and the fleas were noticed on 11 Apr 2013. The vet is unsure if the home was infested, if other animals were in the home, or if the dog was bathed. The product was obtained from the veterinary clinic. The vet did not have lot numbers. No further 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