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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-0968

2. Registrant Information.

Registrant Reference Number: 1-26928863

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.

23-JUL-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

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: Vet Kem 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).

On July 17th, 2011 caller sprayed the home wearing gloves and a mask. Caller became symptomatic for 2 days following application.

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

  • Respiratory System
    • Symptom - Coughing
  • Gastrointestinal System
    • Symptom - Nausea
    • Symptom - Vomiting
  • Nervous and Muscular Systems
    • Symptom - Dizziness

4. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 h

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

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

Chemical resistant gloves

Respirator

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

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

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.)

Caller became symptomatic after product was applied to home, caller claims to have been wearing a mask and gloves during application.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

Signs expected to be mild and self limiting

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: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Gastrointestinal System
    • Symptom - Nausea
  • Nervous and Muscular Systems
    • Symptom - Dizziness

4. How long did the symptoms last?

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

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

Unknown

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Contact with treated area

Amount of time between application and contact 6

Day(s) / Jour(s)

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?

>3 days <=1 wk / >3 jours <=1 sem

12. Time between exposure and onset of symptoms.

>3 days <=1 wk / >3 jours <=1 sem

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.)

Caller said mother became symptomatic 6 days after product was applied on July 17th, 2011. The mother has a slight cough however caller agreed it was probably due to the flu. It was explained to caller that symptoms would have been observed much closer to the time of initial exposure. Advised to seek medical care for her mother if symptoms continued.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

Product was determined doubtfully related by company veterinarian.