Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-0311

2. Registrant Information.

Registrant Reference Number: 08-01-16828818

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.

Human

4. Date registrant was first informed of the incident.

07-NOV-08

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

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. 28382      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Dual Action Flea and Tick Spray for Cats and Kittens

• Active Ingredient(s)
  • (S)-METHOPRENE
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
  • PIPERONYL BUTOXIDE
  • PYRETHRINS

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PMRA Registration No. 19210      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Breakaway Flea and Tick Collar for Cats

• Active Ingredient(s)
  • PROPOXUR

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PMRA Registration No. 25568      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerband Dual Action Flea and Tick Collar for Cats

• Active Ingredient(s)
  • (S)-METHOPRENE
  • TETRACHLORVINPHOS

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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).

Product was applied to animal 3 - 4 years ago and the owner experienced her feet burning. Caller is still experiencing burning feet.

To be determined by Registrant

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

Unknown

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Burning skin

4. How long did the symptoms last?

Unknown / Inconnu

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

Yes

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Application

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

None

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

Caller states that her feet still burn constantly despite the exposure being 3-4 years ago. She stated that she went to hospital. She couldn't walk anymore. She had calluses that were peeled right off. Doctor didn't know what to do. Treatment was worse than the burning. Caller doesn't know what the treatment was.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

Caller was told that symptoms she described do not fit the exposure. Wouldn't expect burning to be present years later. Suggested she continue to work with her MD to rule out other causes and find appropriate treatment.