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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-2750

2. Registrant Information.

Registrant Reference Number: 09-01-18740507

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.

07-JUN-09

5. Location of incident.

Country: UNITED STATES

Prov / State: LOUISIANA

6. Date incident was first observed.

06-JUN-09

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. 2724-497-270

Product Name: Adams Spot On Flea and Tick Control for PTM Under 15 Lbs

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3 %
    • PERMETHRIN
      • Guarantee/concentration 45 %

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: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

The product was applied to 2 small dogs on June 5th.

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.

Other

2. Demographic information of data subject

Sex: Female

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

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Respiratory failure
    • Specify - Respiratory arrest
  • Nervous and Muscular Systems
    • Symptom - Unconsciousness
    • Symptom - Seizure

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?

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

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>8 hrs <=24 hrs / > 8 h < = 24 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 June 6th, the caller's daughter went to hospital and had tests including brain scans to determine reason for seizure. The Prosar specialist advised that with the low incidence of symptoms in pets, would not expect human symptoms due to active ingredient. Maybe coincidence that she had symptoms at same time that product was used. If MD has questions to call back. Exposure route is unclear.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Per Prosar case summary, signs are inconsistent with product exposure. Sleep deprivation is possible cause of seizures.