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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-5659

2. Registrant Information.

Registrant Reference Number: 1-26948829

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-11

5. Location of incident.

Country: UNITED STATES

Prov / State: MARYLAND

6. Date incident was first observed.

06-JUL-11

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. 2724-666-270

Product Name: Bio Spot Room Fogger 3 PK

  • Active Ingredient(s)
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration .4 %
    • PERMETHRIN
      • Guarantee/concentration .4 %
    • PYRETHRINS
      • Guarantee/concentration .05 %
    • PYRIPROXYFEN
      • Guarantee/concentration .1 %

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).

On July 6, 2011 caller's husband fogged home with product.

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

  • Gastrointestinal System
    • Symptom - Nausea
    • Symptom - Diarrhea
    • Symptom - Vomiting
  • Nervous and Muscular Systems
    • Symptom - Muscle weakness
  • Gastrointestinal System
    • Symptom - Other
    • Specify - stomach bleeding
  • General
    • Symptom - Dehydration

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?

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)

Contact with treated area

Amount of time between application and contact 3.5

Hour(s) / Heure(s)

What was the activity? opening windows

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.

>2 hrs <=8 hrs / > 2 h < = 8 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.)

On July 6th 2011 caller became symptomatic after being exposed to product upon re-entry to fogged home. Caller came home several hours after product was applied and started opening windows, turning on fans and turning A/C on. Symptoms continued and was sent to medical center on July 7, 2011. Caller explained she has a medical history of the following: mixed connective tissue disease, immune suppressed, Lupus, Parkinsonism symptoms, rheumatoid arthritis, reactive airway disease, and multiple drug allergies and shellfish allergies.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Caller was discharged on July 10th 2011. Caller had CT scan, blood work and was treated with IV fluids to treat dehydration. Diagnosis was toxicity related to the product upon re-entry to fogged home. Caller indicated her symptoms have improved. This type of reaction is not expected with routine product use. Product was not used according to label directions which specifically state: For use only when building has been vacated by human beings and pets. After two hours, open all outside doors and windows, turn on air conditioners and/or fans and let treated area air for 30 minutes before reoccupying. If additional units are used, increase airing out time accordingly.