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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-1008

2. Registrant Information.

Registrant Reference Number: 1-42284524

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-OCT-15

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

Unknown

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. 25582      PMRA Submission No.       EPA Registration No.

Product Name: VetKem Siphotrol 2000 Double Action Premise Treatment

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • PERMETHRIN

7. b) Type of formulation.

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).

Caller used the product in the home at the end of September. One day after she became symptomatic.

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

  • Skin
    • Symptom - Red skin
  • General
    • Symptom - Swelling

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.

No

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)

Application

Contact with treated area

Amount of time between application and contact 1

Day(s) / Jour(s)

What was the activity? Exposure

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

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.)

One day after using the product in the home, caller became symptomatic. She did not see a doctor.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

Skin exposure to the product may cause a burning, itching, tingling, or numbness sensation. Symptoms typically develop soon after the exposure and resolve spontaneously within 24 hours. In most cases there are no visible changes to the skin. Given the persistence of the symptoms it was recommended that caller seek medical attention. No known direct contact to wet product.