Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-5462

2. Registrant Information.

Registrant Reference Number: 120095508

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.

11-JUL-12

5. Location of incident.

Country: UNITED STATES

Prov / State: LOUISIANA

6. Date incident was first observed.

09-JUL-12

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. 2724-493-270

Product Name: Bio Spot Flea And Tick Collar With IGR For Small Dogs

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 2.1 %
  • 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 July 9, 2012 the owner placed the flea and tick collar on the dog to prevent fleas. It is unknown if collar was fitted 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

Chihuahua

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.92

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• 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 July 9, 2011, a short time after the owner applied the flea and tick collar to the dog, the dog was able to remove the collar and began chewing on it. A short time later, the dog began drooling. The owner took the dog to the veterinarian, but the dog died before any treatment could be given. On July 11, 2012 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that labeled application of the product is considered safe and that accidental ingestion of the collar material carried an intoxication risk. A necropsy was not available.

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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 medium likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected. Unknown if collar was fitted properly on dog.