Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-3798

2. Registrant Information.

Registrant Reference Number: 2017-US-09662

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.

14-JUN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

13-JUN-17

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)

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

Product Name: Activyl Tick Plus for Dogs and Puppies (over 22 lb and up to 44 lb)

• Active Ingredient(s)
  • INDOXACARB TECHNICAL
  • PERMETHRIN
    • Guarantee/concentration 42.5 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

21

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 Jun 2017, a pet owner reported, to the Animal Product Safety Service (APSS), that a dog developed clinical signs after the application of Activyl Tick Plus for Dogs and Puppies (over 22 lb and up to 44 lb). The owner applied the product on 12 Jun 2017. The owner reported she has used the product before with no reactions (date/details unknown). On 13 Jun 2017, the dog became agitated and vomited twice. On 14 Jun 2017, the dog doesn't want to eat or drink. The owner questioned APSS about exposure to chocolate and raisins and what would the outcome be. APSS advised the owner to consult with her veterinarian if those exposures are a possibility. Follow-up on 16 Jun 2017, the owner followed up with APSS, who reported the dog was taken to a clinic on 15 Jun 2017, where it was found the dog was ataxic and anemic with a hematocrit value of 5.0%. It was determined the dog had Immune Mediated Hemolytic Anemia (IMHA). The dog was given a corticosteroid injection. The owner could not afford a transfusion so the dog was sent home. The dog died at home overnight on 16 Jun 2017. The dog was buried. APSS discussed with the owner that the product would definitely not affect the red blood cell count. APSS discussed some animals with heavy flea burdens will become anemic but usually not that low. And APSS discussed if the clinic did have findings consistent with IMHA it was a coincidental timing with the product application. No further information expected.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Pomeranian

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

16

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

• General
  • Symptom - Hyperactivity

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Anorexia

• General
  • Symptom - Adipsia

• Nervous and Muscular Systems
  • Symptom - Ataxia

• Blood
  • Symptom - Anemia
  • Symptom - Other
  • Specify - Immune Mediated Hemolytic Anemia

• General
  • Symptom - Death

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.

Yes

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

corticosteroid injection

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To be determined by Registrant

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

Death

19. Provide supplemental information here