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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-8716

2. Registrant Information.

Registrant Reference Number: 070068389

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.

03-JUL-07

5. Location of incident.

Country: UNITED STATES

Prov / State: ARKANSAS

6. Date incident was first observed.

02-JUL-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: Bio Spot Spot On Flea + Tick Control for Cats + Kittens Under 5 lbs

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 40 %

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

Product Name: Bio Spot Spot Flea + Tick Control for Dogs for Puppies,Toys + Mini

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3 %
    • PERMETHRIN
      • Guarantee/concentration 45 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: vial

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 June 28, 2007 at approximately 5:00 p.m. CDT, the owner applied the cat product to her cat. The product was applied dermally to treat fleas and ticks, and the dose was not appropriate, as the patient was over the weight limit intended for this product use. The same day, the dog product was applied to the owner's dogs, but the owner did not believe there was any chance of the cat being exposed to the dog product, as the pets do not interact.

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

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

15

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Collapse
  • General
    • Symptom - Lethargy
    • Symptom - Pale mucous membrane colour
  • Skin
    • Symptom -
    • Specify - Flea infestation
  • 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.

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

The animal was bathed with liquid dish washing detergent. The owner noticed that the water coming off of the cat was red, due to extreme flea infestation. The APSS staff recommended the owner take the patient to her veterinarian and have the veterinarian call for additional treatment information, the owner refused this due to financial constraints. The patient died on July 4, 2007.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS staff informed the owner that serious systemic and neurologic signs would not be expected from exposure to the cat product. Exposure to the dog product could result in serious signs such as tremors and seizures. APSS stated suspected cause of death is anemia due to heavy flea infestation.