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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-5533

2. Registrant Information.

Registrant Reference Number: 1-30982558

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.

25-JUL-12

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

25-JUL-12

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 .56 %

7. b) Type of formulation.

Other (specify)

fogger

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 applied product in home on July 25, 2012.

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.

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

  • Cardiovascular System
    • Symptom - Chest pain
    • Specify - Chest pain (non-cardia)
    • Symptom - Other
    • Specify - stress related heart problem

4. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

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

Unknown

6. a) Was the person hospitalized?

Yes

6. b) For how long?

3

Day(s) / Jour(s)

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.

Skin

Respiratory

11. What was the length of exposure?

<=15 min / <=15 min

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.)

Caller became symptomatic 30 minutes after applying product in her home on July 25, 2012. She remained in the home for one minute after starting the foggers then left for 2 hours and returned to ventilate home, took aspirin and felt better. Caller was told to see her physician if symptoms worsened. Caller had been previously diagnosed with asthma and was getting over a chest cold at time of call. Caller went to ER at unknown time and was diagnosed with a stress related heart problem and was admitted to hospital to treat her for this condition.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Signs expected to be mild and self limiting. Label directions clearly state to leave the area being treated for at least two hours once activator tab has been locked into position. Caller stayed in room for a while instead of vacating area immediately. Symptoms were determined to be totally unrelated to product use.