Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-8898

2. Registrant Information.

Registrant Reference Number: 070097092

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-SEP-07

5. Location of incident.

Country: UNITED STATES

Prov / State: MISSOURI

6. Date incident was first observed.

11-JUL-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. 2724-497-270

Product Name: Bio Spot Spot On Flea And Tick Control For Dogs <15 lbs 2724-497-270

• 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).

From July 11, 2007 until September 6, 2007 the owner applied the product, once monthly, to the animal as a form of treatment.

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

Chihuahua Dog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

8

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• General
  • Symptom - Hyperactivity

• Nervous and Muscular Systems
  • Symptom - Trembling

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Lethargy

• Nervous and Muscular Systems
  • Symptom - Shaking

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Diarrhea
  • Symptom - Bloody 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 July 11, 2007, the owner noted that the animal was hyperactive. On August 11, 2007, the owner noted that the animal had tremors. The hyperactivity and tremors were both isolated events that resolved on their respective day. On September 11, 2007, the owner noted that the animal had died. On September 11, 2007 the APSS veterinarian stated: "Would not expect blood in the stool from this exposure".

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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

A necropsy was recommended but the animal was already buried. The product was not used according to label directions - label states if signs of sensitivity occur, bath immediately and consult your veterinarian. Owner continued to use product on the animal after it exhibited signs.