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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-5190

2. Registrant Information.

Registrant Reference Number: 2013-US-06230

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.

23-JUL-13

5. Location of incident.

Country: UNITED STATES

Prov / State: SOUTH CAROLINA

6. Date incident was first observed.

23-JUL-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.

1

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 23 Jul 2013, an emergency veterinarian reported, to the ASPCA, that a cat received an application of Activyl Tick Plus for Dogs and Puppies (over 11 lb and up to 22 lb) and had a reaction. The product was purchased from another veterinary clinic. The dog product was accidently applied to the cat to treat fleas. The cat had an isolated seizure and tremors. ASPCA recommended to bathe the cat and provide supportive care. Extra label use due to accidental application on incorrect species. The lot number is not available due to not being provided in ASPCA report. Follow up pending. Follow-up on 29 Jul 2013, by the ASPCA, revealed the cat died on 25 Jul 2013. No further details were available in the ASPCA report. Follow-up with the emergency veterinarian revealed that treatment was being provided to the cat, the cat declined, became unresponsive and died on 25 Jul 2013. A necropsy was not performed. 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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic long hair cross

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

15.8

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

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Muscle tremors
  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Symptom - Unresponsive

12. How long did the symptoms last?

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

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

2

Day(s) / Jour(s)

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

On 23 Jul 2013, an emergency veterinarian reported, to the ASPCA, that a cat received an application of Activyl Tick Plus for Dogs and Puppies (over 11 lb and up to 22 lb) and had a reaction. The product was purchased from another veterinary clinic. The dog product was accidently applied to the cat to treat fleas. The cat had an isolated seizure and tremors. ASPCA recommended to bathe the cat and provide supportive care. Extra label use due to accidental application on incorrect species. The lot number is not available due to not being provided in ASPCA report. Follow-up pending. Follow-up on 29 Jul 2013, by the ASPCA, revealed the cat died on 25 Jul 2013. No further details were available in the ASPCA report. Follow-up with the emergency veterinarian revealed that treatment was being provided to the cat, the cat declined, became unresponsive and died on 25 Jul 2013. A necropsy was not performed. No further information expected.


To be determined by Registrant

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

Death

19. Provide supplemental information here