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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-5576

2. Registrant Information.

Registrant Reference Number: 2011-CA-01172

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.

02-NOV-11

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

01-NOV-11

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. 773-73

Product Name: Defend

  • Active Ingredient(s)
    • PERMETHRIN

7. b) Type of formulation.

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).

Adverse event reaction reported by the clinic. A dog was prescribed Defend because it was diagnosed with a lice problem. The client applied the Defend on 29 Oct 2011, on the mid dorsal section of the dog. The vet explained it should be on the interscapular region of the dog. On 01 Nov 2011, the client noticed the dog developed a raised red swelling, characterized as an acute dermatitis by the attending vet in the area where the Defend was applied. The dog was examined and treated on 02 Nov 2011 with Clavamox and Vanectyl-P. The owner is treating another dog with Defend and no problems reported. The case is ongoing. Update 25 Nov 2011, tried several times to contact attending vet, has not returned any calls. The case is lost to follow up. The case is closed.

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

Dog / Chien

3. Breed

mixed breed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.9

7. Weight (provide a range if necessary )

4.5

kg

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

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

11. List all symptoms

System

  • Skin
    • Symptom - Dermatitis

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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

The dog was examined and treated on 02 Nov 2011 with Clavamox and Vanectyl-P.


To be determined by Registrant

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

Minor

19. Provide supplemental information here