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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-1324

2. Registrant Information.

Registrant Reference Number: 10-01-21603955

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.

08-FEB-10

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

07-NOV-09

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)

PMRA Registration No. 21744      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea Spray for Dogs and Cats

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

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 15 times in one week at an animal grooming facility and an unknown premise product was applied at the same time.

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: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

  • Skin
    • Symptom - Pruritus
  • General
    • Symptom - Swelling
  • Skin
    • Symptom - Red skin
  • Respiratory System
    • Symptom - Shortness of breath
  • Gastrointestinal System
    • Symptom -
    • Specify - salivary gland stopped working
  • Nervous and Muscular Systems
    • Symptom - Muscle weakness

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

Contact with treated area

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 was treated with IV corticosteroids at hospital and sent home with cortisone, Benadryl and an epipen. Caller will be going to the doctor for her salivary issue. Caller was advised to discontinue product use.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

The Prosar specialist advised that the caller follow up with her doctor to determine what she may have reacted to and use caution when using topical flea and tick products.