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: 2007-6980

2. Registrant Information.

Registrant Reference Number: CA2007-00222

Registrant Name (Full Legal Name no abbreviations): SCHERING-PLOUGH ANIMAL HEALTH

Address: 3535 TRANS-CANADA


Prov / State: QUEBEC

Country: CANADA

Postal Code: H9R-1B4

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.


5. Location of incident.

Country: CANADA

Prov / State: MANITOBA

6. Date incident was first observed.


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.


PMRA Registration No. 22968      PMRA Submission No.       EPA Registration No.

Product Name: Defend Exspot

  • Active Ingredient(s)

7. b) Type of formulation.

Application Information

8. Product was applied?


9. Application Rate.


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).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?


Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever

4. Number of animals affected


5. Sex


6. Age (provide a range if necessary )


7. Weight (provide a range if necessary )



8. Route(s) of exposure


9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>2 mos <=6 mos / > 2 mois < = 6 mois

11. List all symptoms


  • Skin
    • Symptom - Irritated skin
    • Symptom -
    • Specify - Staph Folliculitis in large area

12. How long did the symptoms last?

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

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


14. a) Was the animal hospitalized?


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 Event Dog was treated with Defend at end of April and again on or about 18 May 2007. On 30 May, presented at clinic with skin irritation on upper chest. Large area of Staph folliculitis. Shaved, bathed and treated with antibiotics. On 07 June, had spread to areas on back. Baytril was prescribed. 13 June, chest area improving, but neck/back areas not. Continue with Baytril and given oral Prednisone. Attending vet considers this to be a secondary infection with primary reaction to Defend. Case to be followed. FOLLOW-UP 17 July 07: SPAH vet talked with attending vet on 09 July. The dog had shown great improvement and was considered recovered. Vet was to contact owner to check, and call SPAH vet if dog's skin condition not completely healed. No further contact to date. Recovered. Case closed.

To be determined by Registrant

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


19. Provide supplemental information here