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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-1705

2. Registrant Information.

Registrant Reference Number: 2015-US-00335

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.


5. Location of incident.


Prov / State: TEXAS

6. Date incident was first observed.


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.


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


  • Active Ingredient(s)
      • Guarantee/concentration 42.5 %

7. b) Type of formulation.


Application Information

8. Product was applied?


9. Application Rate.


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 14 Jan 2015 a pet owner called to report that he had used Activyl Tick Plus for Dogs and Puppies (over 44 lb and up to 88 lb) monthly since 2013. In September of 2014 the owner reports that the dog had dried skin around her neck under her collar, in one of the areas of application of Activyl, and the dog was scratching at the left rump. Diarrhea and weight loss were also noted. The dog presented to the veterinarian in October 2014 and was treated topically. Activyl was discontinued and the skin healed. In November the dog was straining to defecate (tenesmus), and returned to the veterinarian in January 2015 for ongoing tenesmus and diarrhea. The dog was also on Tri-Heart Plus Chewable Tablets for dogs 50 to 100 pounds monthly for years. The Tri-Heart Plus had not been discontinued and the owner did not believe there was an association. A transitional cell carcinoma of the ureter with metastasis was diagnosed on 05 Jan 2015. The prognosis was poor. The veterinarian stated he did not feel there was an association. The owner stated that he found evidence on the Internet linking Activyl to bladder cancer. The product was purchased at the vet clinic, but the lot number is unknown. Further information is expected.Follow up information received on 17 Apr 2015: the receptionist reported that the dog died on approximately 15 Jan 2015. No necropsy was performed and no further information is expected.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?


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


5. Sex


6. Age (provide a range if necessary )


7. Weight (provide a range if necessary )



8. Route(s) of exposure


9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms


  • General
    • Symptom - Death
    • Symptom - Neoplasia
    • Specify - Urinary neoplasia
  • Skin
    • Symptom - Dry skin
    • Symptom - Pruritus
  • Gastrointestinal System
    • Symptom - Diarrhea
    • Symptom - Weight loss
    • Symptom - Other
    • Specify - tenesmus

12. How long did the symptoms last?

Persisted until death

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


14. a) Was the animal hospitalized?


14. b) How long was the animal hospitalized?

15. Outcome of the incident


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

Pain medications Skin was treated topically

To be determined by Registrant

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


19. Provide supplemental information here

The case became reportable as of 17 April 2015, upon notification the pet had died.