Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-8857

2. Registrant Information.

Registrant Reference Number: 07-1-15397501

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.

09-OCT-07

5. Location of incident.

Country: UNITED STATES

Prov / State: ILLINOIS

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.       PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Powder for Dogs Puppies Cats and Kittens

• Active Ingredient(s)
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 1 %
  • PYRETHRINS
    • Guarantee/concentration .1 %

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7. b) Type of formulation.

Other (specify)

Powder

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).

Caller has used product at his workplace on 3-4 dogs each day for past 12-18 months.

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: Male

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Cardiovascular System
  • Symptom - Other
  • Specify - Dilated Cardiomyopathy

• Blood
  • Symptom - Anemia

• Skin
  • Symptom - Dry 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?

No

6. b) For how long?

7. Exposure scenario

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

Respiratory

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 he uses the product on 3-4 dogs/day, has been doing this for the last 12-18months, reports he is frequently exposed by getting the product on his hands and by "breathing it in." States he has been diagnosed with Dilated Cardiomyopathy with 34% EFI. Also states he has been diagnosed and treated for "severe anemia," reports having a hgb 5. Asking if it is possible that repeated exposure to the product would cause these SX. Asking if there are specific tests available that can detect levels of the product in his body. When asked, states he has also had "dermatological SX" such as "dry/flaky skin, outer layer of skin comes readily, repeats in 3-4 days.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

PROSAR physician advised caller though it is not specifically recommended to wear gloves with standard application of product, because exposures have been repeated, recommended to wear gloves and long sleeves when applying product. Would not expect even chronic exposure to result in the anemia and cardiomyopathy that have been diagnosed. Recommended to continue following up with his HCP for evaluation and treatment of anemia and cardiomyopathy.