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: 2010-0927

2. Registrant Information.

Registrant Reference Number: 090123361

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G5L3

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

Domestic Animal

4. Date registrant was first informed of the incident.

04-NOV-09

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

04-NOV-09

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. 2724-504-270

Product Name: Bio Spot Spot On Flea and Tick Control for Cats and Kittens Under 5 lb

  • Active Ingredient(s)
    • ETOFENPROX
      • Guarantee/concentration 40 %
    • (S)-METHOPRENE
      • Guarantee/concentration 3,6 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

,034

Units: oz (fl) / oz (liquide)

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).

On November 4, 2009 the owner applied the product to the cat. A dog in the household was treated with a Bio Spot for Dogs the same day, but the owner was confident that the cat did not have contact with the dog.

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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Persian

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

4

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
  • Gastrointestinal System
    • Symptom - Oral hemorrhage
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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

On November 4, 2009 the APSS veterinarian stated that with appropriate usage of the product, signs would not be expected. The APSS veterinarian recommended the owner take the cat to the veterinarian, have the veterinarian call for information, and call back with questions. The owner was unable to take the cat to the veterinarian due to financial concerns. An APSS technician relayed the APSS veterinarians recommendations to spot bathe the cat and try calling a humane society for financial help. The owner called back later that same day to state that the cat had died before she could get to a veterinary clinic. An APSS technician relayed the APSS veterinarians recommendations to have the veterinarian call for information on the necropsy and hair testing.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. Necropsy and hair testing samples were obtained by the veterinary clinic on November 5, 2009 pending payment from the owner for the ashes to be returned. On November 11, 2009 an APSS assistant contacted the veterinary clinic to let them know the body was no longer viable for necropsy at this point, but hair testing could still be pursued. Clinic is still awaiting payment from the owner to send hair sample out for testing.