Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3637

2. Registrant Information.

Registrant Reference Number: 2011-CA-00680

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.

09-JUN-11

5. Location of incident.

Country: CANADA

Prov / State: SASKATCHEWAN

6. Date incident was first observed.

31-MAY-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 reaction reported by the clinic. A dog was administered Defend by the owner on 31 May 2011 in the scapular region. Dog was previously at the clinic for vaccination. Received an intranasal canine cough vaccine and a subcutaneous rabies vaccine. Approximately 24 hours post administration of Defend, the dog began to have pruritus, redness and alopecia over the scapular region. On 04 June 2011, the dog began to vomit and have diarrhea. No treatment has been issued. The case is ongoing. After further consultation, the dog was also vaccinated with Imrab 1 and Bronchishield. The clinic will follow up. The case is on going. Follow up 27 June 2011, the clinic reported that the dog fully recovered as of the 10th of June 2011. The case is closed

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

Bichon Frise

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

7.9

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

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • Skin
    • Symptom - Pruritus
    • Symptom - Erythema
  • Gastrointestinal System
    • Symptom - Diarrhea
  • General
    • Symptom - Other
    • Specify - Application site hair change
  • Skin
    • Symptom - Hair loss

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

Fully Recovered / Complètement rétabli

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

Adverse reaction reported by the clinic. A dog was administered Defend by the owner on 31 May 2011 in the scapular region. Dog was previously at the clinic for vaccination. Received an intranasal canine cough vaccine and a subcutaneous rabies vaccine. Approximately 24 hours post administration of Defend, the dog began to have pruritus, redness and alopecia over the scapular region. On 04 June 2011, the dog began to vomit and have diarrhea. No treatment has been issued. The case is ongoing. After further consultation, the dog was also vaccinated with Imrab 1 and Bronchishield. The clinic will follow up. The case is on going. Follow up 27 June 2011, the clinic reported that the dog fully recovered as of the 10th of June 2011. The case is closed


To be determined by Registrant

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

Minor

19. Provide supplemental information here