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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-8874

2. Registrant Information.

Registrant Reference Number: 070077960

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.

25-JUL-07

5. Location of incident.

Country: UNITED STATES

Prov / State: CONNECTICUT

6. Date incident was first observed.

25-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. 2724254

Product Name: Zodiac Fleatrol Flea + Tick Collar for Small Dogs2724254

  • Active Ingredient(s)
    • PROPOXUR
      • Guarantee/concentration 10 %

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).

Owner applied collar to dog.

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

Dog / Chien

3. Breed

Pomeranian

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

Oral

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • General
    • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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 July 25, 2007 at 4:30 p.m. CDT, the owner found the patient dead. When the owner found the patient, the collar was both around her neck and in her mouth. The Animal Product Safety Service (APSS) staff told the caller that propoxur collars are generally well tolerated by dogs. Death from dermal exposure to propoxur is unlikely, so the APSS staff recommended a necropsy be conducted on this patient. .


To be determined by Registrant

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

Death

19. Provide supplemental information here

Product not used according to label directions - "Fit collar snug enough to prevent placement of dog's leg or lower jaw through the collar, yet loose enough to be rotated around the neck." Collar was not fitted properly. The owner was not willing to have a necropsy performed, so no follow-up information is expected in this case