Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-8911

2. Registrant Information.

Registrant Reference Number: 070082064

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Rd. West, Suite 111

City: Guelph

Prov / State: ON

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.

04-AUG-07

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

02-AUG-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No.

Product Name: Bio Spot Spot On Flea And Tick Control For Dogs Puppies Toys And Minis

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

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7. b) Type of formulation.

Liquid

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 August 1, 2007, at 3:00 pm, CDT, the owner applied this product dermally to her puppy as a preventative measure.

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

Parson Russel Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.42

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Diarrhea
  • Symptom - Vomiting
  • Symptom - Drooling

• General
  • Symptom - Death

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Unknown

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

The APSS veterinarian recommended that the owner take the puppy to the veterinarian and have a parvovirus test performed. The APSS veterinarian also recommended that the veterinarian call with any questions. The owner took the puppy to the vet on August 4, 2007 where puppy later died. Attending veterinarian advised APSS puppy's parvovirus test came back positive.

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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

Off label use - product labeled for dogs 6 months of age and over. Puppy was 5 months. The APSS veterinarian stated that given that this is an unvaccinated dog, most concerned about viral diseases such as parvo and distemper. Parvovirus test came back positive. APSS stated product had doubtful likelihood of causing clinical situation. APSS stated parvovirus had high likelihood of causing clinical situation. The owner declined having a necropsy performed.