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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-5677

2. Registrant Information.

Registrant Reference Number: 10-01-24267601

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.

02-OCT-10

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

19-SEP-10

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 2

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

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).

Product was applied to floors and misapplied to mattresses and the caller's children stayed away form the home until the following day.

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.

Other

2. Demographic information of data subject

Sex: Female

Age: >1 <=6 yrs / > 1 < = 6 ans

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Nasal congestion
    • Specify - nasal discharge
    • Symptom - Chest congestion
  • Gastrointestinal System
    • Symptom - Irritated throat
    • Specify - Pharyngitis
  • General
    • Symptom - Fever
    • Symptom - Other
    • Specify - possible Kawasaki disease
  • Skin
    • Symptom - Rash

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?

6

Day(s) / Jour(s)

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.

Skin

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

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

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.)

The caller's daughter developed a runny nose and congestion, but there were no significant findings on lab work. The Prosar Specialist said that it would not be expected to develop symptoms from the product due to time frame of exposure after application and the fact that they are persisting. The caller was told to wash the treated surfaces with an appropriate household cleaner along with washing all bedding. The Specialist also advised to follow up with MD if symptoms persist. The daughter was taken to a physician and due to throat swelling was hospitalized and released the next day. Two days later, the daughter developed a high fever and rash and was hospitalized for five days. She was diagnosed with incomplete Kawasaki disease, but no significant findings on lab work. the daughter has been home for 2 weeks and has been asymptomatic since being released from the hospital.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

This product was not used according to label directions: not labelled for use on mattresses.