Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4841

2. Registrant Information.

Registrant Reference Number: 2023-CA-000169

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

Packaging Failure

4. Date registrant was first informed of the incident.

17-MAY-23

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

17-MAY-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. 25582      PMRA Submission No.       EPA Registration No.

Product Name: VetKem Siphotrol 2000

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

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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).

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?

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: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Salivating excessively

4. How long did the symptoms last?

Unknown / Inconnu

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)

Contact with treated area

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

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>2 hrs <=8 hrs / > 2 h < = 8 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 16 May 2023, the product was applied inside a residence by the consumer. Additional foam-like material was noted to be dispensed from a small hole in the packaging while the product was being applied. Approximately 4 hours after product application a chemical smell was noted. On 17 May 2023, the consumer developed increased salivation. Consumer has a history of increased salivation when in the presence of other insecticide products. No further information is expected.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

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. Signs are expected to be mild and self-limiting.

Subform VI: Packaging Failure

1. What is the type of packaging that failed?

Pressurized product /Prod. sous pression

2. Did packaging failure occur during?

Use of Product

3. Did packaging failure result in?

potential injury

potential exposure

4. Describe how the packaging failed and the surrounding circumstances, including a description of the potential injury or exposure.

On 17 May 2023, the consumer reported that when the product was applied on 16 May 2023 the product appeared to be leaking extra material from a small hole near where product was intended to be dispensed from the packaging when applied. The extra product was dispensed as a foam. Consumer noted that there was the potential for a larger than intended amount of product exposure due to this. Consumer noted a chemical odor approximately 4 hours after product use. On 17 May 2023, the consumer noted increased salivation. No further information is expected.

For Registrant use only

5. Provide supplemental information here.

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.