Health Canada
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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-4358

2. Registrant Information.

Registrant Reference Number: 09-01-19995751

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.

17-SEP-09

5. Location of incident.

Country: UNITED STATES

Prov / State: MASSACHUSETTS

6. Date incident was first observed.

14-SEP-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.       PMRA Submission No.       EPA Registration No. 2724-454

Product Name: Zodiac Fleatrol Fogger

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .09 %
    • PERMETHRIN
      • Guarantee/concentration .58 %

7. b) Type of formulation.

Other (specify)

Fogger

Application Information

8. Product was applied?

Yes

9. Application Rate.

6

Units: oz (wts) / oz (pds)

10. Site pesticide was applied to (select all that apply).

Site: Res. - In Home / Rés. - à l'int. maison

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Child's exposure was 18 hours after the release of the product. in the home.

To be determined by Registrant

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

Yes

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

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Male

Age: <=1 yr / < = 1 an

3. List all symptoms, using the selections below.

System

  • Gastrointestinal System
    • Symptom - Diarrhea
  • Nervous and Muscular Systems
    • Symptom - Unconsciousness
    • Specify - loss of consciousness

4. How long did the symptoms last?

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

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

1

Day(s) / Jour(s)

7. Exposure scenario

Non-occupational

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

Contact with treated area

What was the activity? re-entry

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

Oral

11. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

12. Time between exposure and onset of symptoms.

>30 min <=2 hrs / >30 min <=2 h

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.)

The Prosar Specialist advised that small ingestions of the product are unlikely to result in adverse health effects other than a mild GI upset if enough product was ingested. Specialist recommended working with the physicians to evaluate cause of symptoms and to please call back with any additional questions or concerns.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Test results showed that phenothrin was found in the child's sytem. Zodiac Fleatrol Fogger does not contain phenothrin.