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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3140

2. Registrant Information.

Registrant Reference Number: 2013-US-03277

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.

03-MAY-13

5. Location of incident.

Country: UNITED STATES

Prov / State: VIRGINIA

6. Date incident was first observed.

03-MAY-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.

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 03 May 2013 an office manager called to report a suspected adverse reaction to ActivylTick Plus for Dogs and Puppies (over 44 lb and up to 88 lb). The product was applied to a Korean Jindo dog on 03 May 2013. The dog immediately started to vomit and became lethargic. The owner gave the dog a bath. On 07 May 2013 the vet reported that the dog was not improving and bloodwork revealed elevated hepatic enzymes. The dog is being treated symptomatically. The product was purchased from the clinic. Follow up is pending. Follow up: On 07 Jun 2013 a vet reported that the dog was euthanized on 06 Jun 2013. The dog had been treated supportively and was doing well. The owners gave another company's heartworm medication on 03 Jun 2013 and the dog then did poorly (crashed) and they elected euthanasia. No necropsy was performed. No further information is expected in this case. EMA reportability: case initially reported as non-serious, changed from periodic to 15-Day Alert on 07 June 2013, as the dog was euthanized.

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

Korean Jindo

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8.0

7. Weight (provide a range if necessary )

48.0

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

<=30 min / <=30 min

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Lethargy
  • Liver
    • Symptom - Elevated liver enzymes
  • General
    • Symptom - Other
    • Specify - dog crashed

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

Yes

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 03 May 2013 an office manager called to report a suspected adverse reaction to Activyl Tick Plus for Dogs and Puppies (over 44 lb and up to 88 lb). The product was applied to a Korean Jindo dog on 03 May 2013. The dog immediately started to vomit and became lethargic. The owner gave the dog a bath. On 07 May 2013 the vet reported that the dog was not improving and bloodwork revealed elevated hepatic enzymes. The dog is being treated symptomatically. The product was purchased from the clinic. Follow up is pending. Follow up: On 07 Jun 2013 a vet reported that the dog was euthanized on 06 Jun 2013. The dog had been treated supportively and was doing well. The owners gave another company's heartworm medication on 03 Jun 2013 and the dog then did poorly (crashed) and they elected euthanasia. No necropsy was performed. No further information is expected in this case. EMA reportability: case initially reported as non-serious, changed from periodic to 15-Day Alert on 07 June 2013, as the dog was euthanized.


To be determined by Registrant

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

Death

19. Provide supplemental information here