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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-5191

2. Registrant Information.

Registrant Reference Number: 2013-US-06090

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.

19-JUL-13

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

16-JUL-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. 773-94

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).

On 19 Jul 2013 a veterinarian reported a possible adverse reaction following the use of Activyl Tick Plus for Dogs and Puppies (over 44 lb and up to 88 lb). The Activyl Tick Plus was purchased at the vet clinic on 12 Jul 2013 and applied to the dog by the owner on 15 Jul 2013. The dog was described as not being right and was staggering on 16 Jul 2013. By 17 Jul 2013 the dog was recumbent and had developed diarrhea. Treatment options are being considered. The veterinarian also reported that another dog appeared dumb for a week after application of Activyl Tick Plus in April of 2013. Follow-up is pending. Follow-up on 29 Jul 2013: The dog was euthanized on 20 Jul 2013. 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

Siberian Husky

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

65.0

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

  • Nervous and Muscular Systems
    • Symptom - Staggering
  • General
    • Symptom - Malaise
  • Nervous and Muscular Systems
    • Symptom - Recumbent
  • Gastrointestinal System
    • Symptom - Diarrhea

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

Unknown

14. a) Was the animal hospitalized?

Unknown

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

On 19 Jul 2013 a veterinarian reported a possible adverse reaction following the use of Activyl Tick Plus for Dogs and Puppies (over 44 lb and up to 88 lb). The Activyl Tick Plus was purchased at the vet clinic on 12 Jul 2013 and applied to the dog by the owner on 15 Jul 2013. The dog was described as not being right and was staggering on 16 Jul 2013. By 17 Jul 2013 the dog was recumbent and had developed diarrhea. Treatment options are being considered. The veterinarian also reported that another dog appeared dumb for a week after application of Activyl Tick Plus in April of 2013. Follow-up is pending. Follow-up on 29 Jul 2013: The dog was euthanized on 20 Jul 2013. 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