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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-5870

2. Registrant Information.

Registrant Reference Number: 2014-US-11180

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.

04-DEC-14

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

01-JUN-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.

6

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 lack of expected efficacy: On 04 Dec 2014 a technician reported fleas on an 85 lb dog that was treated with Activyl Tick Plus for Dogs and Puppies (over 88 lb and up to 132 lb, extra-label use) around 01 Apr 2013 (exact date unknown). The date the fleas were noticed is unknown. The dog was not treated. The dog died around 01 Jun 2013 (exact date unknown) due to geriatric related problems and thyroid disease. The product was purchased at a veterinary clinic. Limited information available. No more information expected.11 Dec 2014 Follow-up: Start date of clinical sign "unrelated death" corrected.

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

Dog / Chien

3. Breed

Golden Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10.5

7. Weight (provide a range if necessary )

85.0

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

>1 mo <=2 mos / > 1 mois < = 2 mois

11. List all symptoms

System

  • General
    • Symptom - Death

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

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

Suspected adverse event and lack of expected efficacy: On 04 Dec 2014 a technician reported fleas on an 85 lb dog that was treated with Activyl Tick Plus for Dogs and Puppies (over 88 lb and up to 132 lb, extra-label use) around 01 Apr 2013 (exact date unknown). The date the fleas were noticed is unknown. The dog was not treated. The dog died around 01 Jun 2013 (exact date unknown) due to geriatric related problems and thyroid disease. The product was purchased at a veterinary clinic. Limited information available. No more information expected. 11 Dec 2014 Follow-up: Start date of clinical sign "unrelated death" corrected.


To be determined by Registrant

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

Death

19. Provide supplemental information here