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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-0605

2. Registrant Information.

Registrant Reference Number: US2007-01519

Registrant Name (Full Legal Name no abbreviations): Schering-Plough Canada Inc.

Address: 3535 Trans-Canada

City: Pointe-Claire

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.

29-JUN-07

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

29-JUN-07

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.

Product Name: Defend Exspot for Dogs

  • Active Ingredient(s)
    • PERMETHRIN
      • Guarantee/concentration 65 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.5

Other Units: cc

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).

0.5cc; topical

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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

12

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Symptom - Trembling
  • General
    • Symptom - Death

12. How long did the symptoms last?

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

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

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

Owner, (name) advised that she had treated two cats with about 0.5 cc Defend a few hours ago and now one was seizuring and tremoring. She had bathed both cats with Dawn dishwashing detergent. I advised that she seek immediate veterinary care and did not request further information from her. Dr. (name) (attending vet) later advised that the affected cat had been presented to his clinic and they were under treatment with Robaxin and diazepam. His technician advised that an initial iv dose of Robaxin had not controlled the seizures and that they were going to administer further treatment. The product lot number is not available as the owner was advised to seek immediate veterinary attention. A follow-up call is planned. FOLLOW-UP: The treated cat died and the other cat was not brought in for treatment.


To be determined by Registrant

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

Death

19. Provide supplemental information here