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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-5453

2. Registrant Information.

Registrant Reference Number: 2013-US-07554

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.

06-SEP-13

5. Location of incident.

Country: UNITED STATES

Prov / State: MASSACHUSETTS

6. Date incident was first observed.

03-SEP-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. 773-94

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.

Unknown

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 06 Sep 2013 a veterinarian called to report that on approximately 03 Sep 2013 a stray cat at a shelter had either Activyl or Activyl Tick Plus applied and within the day experienced seizures and tremors. It was presumed the content of the bottle was Activyl Spot On for Dogs and Puppies (Extra label use species), but the veterinarian believes Activyl TickPlus for Dogs and Puppies was applied instead (Extra label use - species.) Because other cats experienced similar signs after being dosed with product from the same poorly labeled common jar, the veterinarian presumes an error was made and the product Activyl Tick Plus for Dogs and Puppies was applied inadvertently. These other cases were reported separately due to different outcomes (case 2013 US 07555 and 2013 US 07559). This cat was euthanized, as the shelter was initially afraid of an infectious disease process. The product was obtained at the shelter. Hair testing is being performed on another cat/case to confirm use of permethrin. No further information is expected. Follow up received 27 Sep 2013 Hair analysis in case 2013 US 07559 showed two compounds 1) Indoxacarb (large amount). 2) Permethrin (large amount). The toxicologist s comment was These ingredients are consistent with the flea and tick product Activyl plus. No further information is 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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

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

  • Nervous and Muscular Systems
    • Symptom - Convulsions
    • Symptom - Muscle tremors

12. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 h

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

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 06 Sep 2013 a veterinarian called to report that on approximately 03 Sep 2013 a stray cat at a shelter had either Activyl or Activyl Tick Plus applied and within the day experienced seizures and tremors. It was presumed the content of the bottle was Activyl Spot-On for Dogs and Puppies (Extra label use species), but the veterinarian believes Activyl TickPlus for Dogs and Puppies was applied instead (Extra label use species.) Because other cats experienced similar signs after being dosed with product from the same poorly labeled common jar, the veterinarian presumes an error was made and the product Activyl Tick Plus for Dogs and Puppies was applied inadvertently. These other cases were reported separately due to different outcomes (case 2013 US-07555 and 2013 US 07559). This cat was euthanized, as the shelter was initially afraid of an infectious disease process. The product was obtained at the shelter. Hair testing is being performed on another cat case to confirm use of permethrin. No further information is expected. Follow up received 27 Sep 2013 Hair analysis in case 2013 US 07559 showed two compounds 1) Indoxacarb (large amount). 2) Permethrin (large amount). The toxicologis s comment was These ingredients are consistent with the flea and tick product Activyl plus. No further information is expected.


To be determined by Registrant

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

Death

19. Provide supplemental information here