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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3845

2. Registrant Information.

Registrant Reference Number: 1-25654945

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.

21-MAR-11

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

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).

Caller sprayed her home every day for three weeks in a row beginning shortly after February 27, 2011 (date she started spraying the home is undetermined)

To be determined by Registrant

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

No

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

  • General
    • Symptom - Other
    • Specify - chest pain (inc non-cardia)
  • Gastrointestinal System
    • Symptom - Dry throat
  • Respiratory System
    • Symptom - Coughing
    • Symptom - Other
    • Specify - green mucus
    • Symptom - Shortness of breath

4. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

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)

Unknown

10. Route(s) of exposure.

Respiratory

11. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

12. Time between exposure and onset of symptoms.

>1 wk <=1 mo / > 1 sem < = 1 mois

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 became symptomatic after spraying her home with the product, the date is not specific but some time after February 27th, 2011. Caller was spraying the home every day including her car for three weeks therefore symptoms continued. Caller stated she did not read label. She was instructed to follow all directions for use on the container, however was recommended that use of the product be discontinued until her symptoms improve. Caller was also instructed to keep away from the fumes and stay in an area with fresh air and adequate ventilation and to ventilate the home by opening outside doors and windows. Caller was instructed to contact a health care professional if symptoms continued after 30 minutes.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

Inappropriate use of product, caller did not follow safety directions on label which state: Avoid contact with skin, eyes and clothing. Harmful if swallowed, inhaled or absorbed through the skin. Avoid breathing mist. On March 23rd, 2011 follow up call was placed, her symptoms have improved.