Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-2581

2. Registrant Information.

Registrant Reference Number: 090054492

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.

19-MAY-09

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

17-MAY-09

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. 2724-497-270

Product Name: BioSpot Spot On Flea And Tick Control For Puppies, Toys and Miniatures

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 3 %
  • PERMETHRIN
    • Guarantee/concentration 45 %

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-493-270

Product Name: Adams Plus Flea and Tick Collar For Large Dogs

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 2.1 %
  • PROPOXUR
    • Guarantee/concentration 10 %

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7. b) Type of formulation.

Liquid

Other (specify)

collar

Application Information

8. Product was applied?

Yes

9. Application Rate.

.034

Units: oz (fl) / oz (liquide)

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 April 1, 2009, and May 1, 2009, the owner applied the wrong dose of Spot On product to the dog to treat a flea infestation. On April 30, 2009, the owner applied the wrong sized collar to the dog to treat a flea infestation.

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

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

16

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>1 mo <=2 mos / > 1 mois < = 2 mois

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia

• Respiratory System
  • Symptom - Runny nose
  • Specify - Nasal Discharge

• Gastrointestinal System
  • Symptom - Diarrhea

• 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 May 18, 2009, the dog began eating again. On May 19, 2009, the owner found the dog dead. The APSS technician stated that no significant signs would be expected from this exposure. She 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. The owner declined a necropsy because the body was no longer available. The incorrect size collar and the incorrect dose of Spot On was used.