Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6490

2. Registrant Information.

Registrant Reference Number: 130128778

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.

13-SEP-13

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

13-SEP-13

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 4, 2013 the owner applied the product to the dog to treat for fleas. On September 13, 2013 the owner noticed that the dog got the collar in her mouth. Unknown if owner fitted collar properly.

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

Dog / Chien

3. Breed

Pug

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

23.0

lbs

8. Route(s) of exposure

Skin

Oral

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

• Nervous and Muscular Systems
  • Symptom - Seizure

• Gastrointestinal System
  • Symptom - Drooling

• 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 September 13, 2013, shortly after discovering that the dog had the collar in her mouth, the owner noticed that the dog was symptomatic; the owner immediately removed the collar. The owner observed that the dog died suddenly several minutes later, before she could get to a veterinary clinic. Later that morning the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the main concern was for gastrointestinal (GI) upset and a taste reaction with an oral exposure. The APSS veterinarian also stated that it would not be expected that the dog would get the collar caught in her mouth, have a seizure, and then die immediately; the owner did not believe the dog could have choked on the collar, though. The APSS veterinarian recommended that the owner call back with questions.

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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. A necropsy was not available. Unknown if owner properly fitted collar.