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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-8882

2. Registrant Information.

Registrant Reference Number: 070083413

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

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: ON

Country: Canada

Postal Code: N1G 5L3

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

Domestic Animal

4. Date registrant was first informed of the incident.

07-AUG-07

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

6. Date incident was first observed.

02-AUG-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. 2724272

Product Name: Zodiac Fleatrol Flea Collar For Cats Of All Sizes2724272

  • Active Ingredient(s)
    • CARBARYL
      • Guarantee/concentration 9.5 %

7. b) Type of formulation.

Other (specify)

Collar

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: Collar

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 July 17, 2007, the owner put the collar on the cat.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Lethargy
    • Symptom - Death

12. How long did the symptoms last?

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

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 kitten was a stray - age, weight and medical history unknown.. The kitten had a significant flea burden. The Animal Product Safety Service (APSS) staff stated that the signs were not consistent with a collar, and that it was critical to have the kitten seen by a DVM since he has not eaten for 4-5 days. The APSS staff recommended that the owner take the animal to the veterinarian and have the veterinarian call back for information. The APSS staff also recommended that the veterinarian give a physical examination, a diagnostic evaluation, to provide supportive and symptomatic care as needed, and to call back with questions. Kitten died on August 8, 2007.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Due to length of time between application of product and on set of symptoms, signs not consistent with collar. APSS staff determined that this product was considered to have doubtful likelihood of causing the clinical situation. APSS discussed possiblity of parasitism, infection disease and flea anemia. APSS also recommended that a necropsy be performed, but the cat had already been buried.