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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-2936

2. Registrant Information.

Registrant Reference Number: 2013-US-03136

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.

30-APR-13

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

Unknown

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.

.5

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 30 Apr 2013 a hospital manager called to report red and itchy skin reaction several hours after the Activyl Tick Plus Small Dog/Puppies 11 to 22 lbs was applied. The date of application is unknown, the dog recovered after 2 to 3 days after initial application with no treatment given. The dog had a history of heart disease, and recently the dog had a stroke and would not eat or drink. The owners decided to have the dog euthanized on 26 Apr 2013. This was not product related. The product purchased at the veterinary clinic. No more information expected.

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

Maltese

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

12.4

7. Weight (provide a range if necessary )

5.6

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

Unknown / Inconnu

11. List all symptoms

System

  • Skin
    • Symptom - Itchy skin
    • Symptom - Red skin
  • Cardiovascular System
    • Symptom - Stroke
  • General
    • Symptom - Adipsia
  • Gastrointestinal System
    • Symptom - Anorexia

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

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 30 Apr 2013 a hospital manager called to report red and itchy skin reaction several hours after the Activyl Tick Plus Small Dog/Puppies 11 to 22 lbs was applied. The date of application is unknown, the dog recovered after 2 to 3 days after initial application with no treatment given. The dog had a history of heart disease, and recently the dog had a stroke and would not eat or drink. The owners decided to have the dog euthanized on 26 Apr 2013. This was not product related. The product purchased at the veterinary clinic. No more information expected.


To be determined by Registrant

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

Death

19. Provide supplemental information here