Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-6107

2. Registrant Information.

Registrant Reference Number: 070043231

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

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: ON

Country: Canada

Postal Code: N1G 5L3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

04-MAY-07

5. Location of incident.

Country: UNITED STATES

Prov / State: MISSOURI

6. Date incident was first observed.

30-APR-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 Medium Size 31-60lbs

• 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.

.068

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 4/30/07 at 11:49 am, CDT, the caller's sister applied the product on the dog.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Golden Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

50

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Respiratory System
  • Symptom - Wheezing

• 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

Not recovered / Non rétabli

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 4, 11:49 am CDT, the owner called into the APSS facility to report this exposure. The animal was taken to the veterinary clinic but it is unknown if it was pre or post mortem. The attending DVM contacted the APSS facility at 1:34 pm, CDT on May 4th to state that the animal's dead body was brought into his clinic. The attending DVM stated that he may be able to send some tissues for necropsy but not the whole body. The APSS veterinarian stated that he would fax the necropsy protocol paperwork to his clinic. On August 2, 2007 the necropsy results on the said animal were obtained from the (lab name). According to the results marked cystic hyperplasia with marked suppurative endometritis were discovered. The (lab name) DVM stated "pyometra would explain the demise of the dog".

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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 this product has a good safety margin in dogs and is well tolerated. Necropsy results indicated the (lab name) DVM stated "pyometra would explain the demise of the dog". APSS veterinarian stated the signs that the animal was displaying are not consistent with exposure to this product; therefore, it is unlikely that the death is related to this exposure.