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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-3730

2. Registrant Information.

Registrant Reference Number: 10-01-23577748

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.

26-JUL-10

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

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)

PMRA Registration No. 23075      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Premise Plus Flea Spray

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

PMRA Registration No. 25695      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Premise 2000 Flea Spray

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

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: 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).

Both product were applied to home one time in the last month.

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

  • Respiratory System
    • Symptom - Difficulty Breathing
    • Symptom - Other
    • Specify - felt like lungs filling up

4. How long did the symptoms last?

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

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

No

6. a) Was the person hospitalized?

No

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.

Respiratory

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

<=30 min / <=30 min

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.)

Products were applied to home about a month ago and caller wanted to know if she can use the product now that she found out she is pregnant. Caller felt she was sensitive to odor and there was ventilation, windows were open. The Prosar Specialist advised that there are no human reproductive studies; therefore we can not guarantee safety of exposure during pregnancy. The specialist recommended that someone else spray the product in the house and she leave the house while it is treated.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.