Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-5664

2. Registrant Information.

Registrant Reference Number: 110125167

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.

29-SEP-11

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

28-SEP-11

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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-254

Product Name: Zodiac Fleatrol Flea and Tick Collar for Small Dogs

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

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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 September 24, 2011 the owner placed the flea and tick collar on the dog to prevent fleas.

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

Dog / Chien

3. Breed

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.29

7. Weight (provide a range if necessary )

3.0

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 - Seizure

• 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

At an unknown date and time the owners wiped the dog's coat and skin with puppy wipes and bathed the dog with an unknown product. On September 28, 2011 the owner noticed the dog was symptomatic. While the dog was having the seizure, the flea and tick collar may have gotten into the dog's mouth. The dog died a short time later. After the dog died, the owner took the dog to the veterinarian. On September 29, 2011 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the dermal application of the flea and tick collar would be expected to cause minimal clinical signs. The APSS veterinarian also stated that significant systemic effects, including death, were not expected. The APSS assistant recommended a necropsy.

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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. On September 30, 2011 the owner called the APSS and stated that he had had the dog cremated, so a necropsy was not available.