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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-5652

2. Registrant Information.

Registrant Reference Number: 1-27778109

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.

21-OCT-11

5. Location of incident.

Country: UNITED STATES

Prov / State: CONNECTICUT

6. Date incident was first observed.

01-MAY-11

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. 2724-490

Product Name: Vet Kem Siphotrol Plus II Premise Spray 16 oz

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .085 %
    • D-PHENOTHRIN
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration 2 %
    • PERMETHRIN
      • Guarantee/concentration .35 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 1.4 %

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 sprayed in the house on October 16th, 2011, product has been used in home since May, caller has used 10 cans to date.

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

  • Nervous and Muscular Systems
    • Symptom - Headache
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Vomiting
  • Nervous and Muscular Systems
    • Symptom - Memory loss
    • Specify - forgetfulness and senility
  • Respiratory System
    • Symptom - Coughing
    • Specify - cough

4. How long did the symptoms last?

>2 mos and <=6mos />2 mois et <=6mois

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

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.

Respiratory

Unknown

11. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

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 first applying product in May 2011 however is calling for the first time on October 21st, 2011 after applying product in her home on October 16th. Caller also states her son was setting off flea bombs in her house on Sunday October 16th. Caller also explained that she suffers from chronic disease immune deficiency syndrome and pain from being hit by a truck in 2004. The caller states that she thinks that she has inhaled some of the Siphotrol product however she also states that she does not smell any of the product fumes and has followed all of the label directions as far as application and re-entry times.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Recommended that she ventilate the area by opening outside doors and windows. The caller stated that she has a very large house and thinks that there is adequate ventilation which ignores label instructions which say to ventilate thoroughly before re-entry. It was also recommended that she be evaluated by a physician for her symptoms