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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-3419

2. Registrant Information.

Registrant Reference Number: 10-01-22867572

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.

03-JUN-10

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

30-MAY-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. 2724-401-2596

Product Name: UltraGuard Plus Flea and Tick Home Spray

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .01 %
    • PERMETHRIN
      • Guarantee/concentration .28 %

7. b) Type of formulation.

Liquid

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 on the furniture on May 30th.

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: Male

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

3. List all symptoms, using the selections below.

System

  • Skin
    • Symptom - Discolouration
    • Specify - red-purple blotches
  • General
    • Symptom - Other
    • Specify - abnormal mentation
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • Respiratory System
    • Symptom - Coughing
  • Cardiovascular System
    • Symptom - Cardiac arrest
  • Respiratory System
    • 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?

Yes

6. b) For how long?

5

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? slept on the furniture

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.

Unknown

11. What was the length of exposure?

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

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.)

The product was applied to the furniture on May 30th., 2010 and that night the caller's husband slept on the coach after ventilating treated area. The caller's husband has seizures that night and was taken to the hospital where he was bathed. The caller's husband was released from the hospital on oxygen and husband feels better outside of house. The symptoms described are not expected for exposure. Caller was advised to continue to work with the MD on a diagnosis.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Patient was advised that inhalation usually results in adverse effects typically limited to the upper respiratory tract which resolves without affecting other body functions. Ventilating the area as well as washing treated surfaces with an appropriate household cleaner may be needed.