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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-2325

2. Registrant Information.

Registrant Reference Number: 2013-US-02074

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.

29-MAR-13

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

08-MAR-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).

Suspected lack of efficacy: On 29 Mar 2013 a vet tech reported that two dogs still had fleas following use of Activyl TickPlus for Dogs and Puppies (over 44 lb and up to 88 lb) and Activyl TickPlus for Dogs and Puppies (over 88 lb and up to 132 lb). The product was applied on 29 Jan 2013. Fleas were still seen one week later on 05 Feb 2013. The dogs are housed outdoors. The dogs were flea bathed and the environment was treated with an unknown product. On approximately 08 Mar 2013 one dog died from natural causes. The product was obtained from the veterinary hospital. No further information is 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

Great Dane

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

95

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

>1 mo <=2 mos / > 1 mois < = 2 mois

11. List all symptoms

System

  • General
    • Symptom - Death

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

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

Suspected lack of efficacy: On 29 Mar 2013 a vet tech reported that two dogs still had fleas following use of Activyl Tick Plus for Dogs and Puppies (over 44 lb and up to 88 lb) and Activyl Tick Plus for Dogs and Puppies (over 88 lb and up to 132 lb). The product was applied on 29 Jan 2013. Fleas were still seen one week later on 05 Feb 2013. The dogs are housed outdoors. The dogs were flea bathed and the environment was treated with an unknown product. On approximately 08 Mar 2013 one dog died from natural causes. The product was obtained from the veterinary hospital. 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