Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-6206

2. Registrant Information.

Registrant Reference Number: 2023-US-035998

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

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.

17-SEP-23

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

6. Date incident was first observed.

17-SEP-23

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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-454

Product Name: Zoecon Precor Plus Fogger

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .09 %
  • PERMETHRIN
    • Guarantee/concentration .58 %

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7. b) Type of formulation.

Other (specify)

Fogger

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).

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

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: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Shaking

• General
  • Symptom - Other
  • Specify - Feeling freezing

• Gastrointestinal System
  • Symptom - Other
  • Specify - Gallbladder infection

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?

Unknown

6. b) For how long?

7. Exposure scenario

Non-occupational

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

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.

Unknown

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

<=30 min / <=30 min

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 17 Sep 2023, a person set off the fogger in the house. Approximately 5 minutes after product use, the person developed vomiting, shaking, and feeling as though he was freezing. The person was seen at an emergency room where infection of the gall bladder was diagnosed. Surgery to remove the gall bladder was performed. On 19 Sep 2023, the person was recovering at home. The treating doctor relayed to the person being treated that clinical signs were not caused by the product. No further information is expected

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Considering the short onset of the symptoms in regard to the product exposure and the provided diagnosis of gallbladder infection, it is unlikely and unexpected that the product could have caused an infection. The information contained in this report is based on self-reported statements provided to the registrant during telephone interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and cannot form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. This was an extra label use due to potential secondary exposure.