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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-2301

2. Registrant Information.

Registrant Reference Number: 2015-US-05143

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: NEW YORK

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 19 May 2015, an animal owner reported that her dog developed multiple clinical signs after Activyl Tick Plus for Dogs and Puppies (over 22 lb and up to 44 lb) was applied on 14 May 2015. On approximately 16 May 2015, the dog developed lethargy and fell over and then on approximately 17 May 2015, developed multiple episodes of vomiting and anorexia. An examination on 18 May 2015 revealed 2 kg of weight loss since Jul 2014, an elevated white blood cell count (27,000/mcl, normal less than 17,000), an elevated neutrophil count (24, 000/mcl, normal 3000-12,000), an elevated ALT (257 U/L, normal 10-118), an elevated ALKP (417 U/L, normal 20-150), and an elevated total bilirubin (0.8mg/dl, normal 0.1-0.6). Results of radiographs on 19 May 2015 showed abdominal effusion, rounding of the liver (coded as liver disorder), lymphadenopathy of the mediastinum, and an interstitial lung pattern (coded as abnormal radiograph finding). The dog was treated with liver supplements, antibiotics, and a probiotic. On 22 May 2015, the owner reported that the dog had died on 19 May 2015. A necropsy was not performed. No more 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Shetland Sheep Dog(Sheltie)

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms


  • General
    • Symptom - Death
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Specify - Falling over
  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Vomiting
    • Symptom - Weight loss
  • Blood
    • Symptom - Leukocytosis
    • Symptom - Leukocytosis
    • Specify - Neutrophilia
  • Liver
    • Symptom - Elevated liver enzymes
    • Symptom - Other
    • Specify - Elevated Total Bilirubin
    • Symptom - Other
    • Specify - radiographs show rounding of the liver
  • Gastrointestinal System
    • Symptom - Other
    • Specify - Abdominal effusion
  • General
    • Symptom - Other
    • Specify - lymphadenopathy of the mediastinum
  • Respiratory System
    • Symptom - Other
    • Specify - interstitial lung pattern seen as radiograph finding

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

treatment; liver supplements antibiotics probiotic

To be determined by Registrant

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


19. Provide supplemental information here