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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-5360

2. Registrant Information.

Registrant Reference Number: 080116763448

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.

20-OCT-08

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

08-OCT-08

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. 2724-774-43591

Product Name: Mycodex Plus Environmental Control Aerosol Household Spray

  • Active Ingredient(s)
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration 1 %
    • PERMETHRIN
      • Guarantee/concentration .2 %
    • PROPOXUR
      • Guarantee/concentration .015 %

7. b) Type of formulation.

Other (specify)

Aerosol

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).

Home treated 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.

Other

2. Demographic information of data subject

Sex: Female

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • General
    • Symptom - Weakness
    • Symptom - Lightheadedness
  • Gastrointestinal System
    • Symptom - Vomiting
  • Respiratory System
    • Symptom - Pneumonia
    • Specify - Aspirated pneumonia

4. How long did the symptoms last?

Unknown / Inconnu

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

Unknown

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.

Respiratory

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

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.)

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Symptoms are typically self-limiting and subside with removal of the odor. It was advised to ventilate the area by opening outside windows and doors. Consider adding portable fans until the odor has dissipated. A (name) rep also suggested having the carpets steam cleaned to remove product. Would recommend that subject continue to work with her physicians. Please have the treating physician call back with any other questions.

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: Male

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Irritated throat
    • Symptom - Asthma

4. How long did the symptoms last?

Unknown / Inconnu

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)

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.

Respiratory

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

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.)

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Symptoms are typically self-limiting and subside with removal of the odor. It was advised to ventilate the area by opening outside windows and doors. Consider adding portable fans until the odor has dissipated. A (name) rep also suggested having the carpets steam cleaned to remove product. Would recommend that this patient continue to work with his physicians. Please have the treating physician call back with any other questions. People with underlying respiratory conditions should exercise caution with use of any aerosol product. Patient's doctor diagnosed aspirated pneumonia but did not feel diagnosis related to product.