Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-0705

2. Registrant Information.

Registrant Reference Number: 2022-CA-000440

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.

19-OCT-22

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)

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PMRA Registration No. 25695      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Premise 2000 Flea Spray

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

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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: Unknown

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Dyspnea
  • Symptom - Shortness of breath
  • Symptom - Respiratory pain
  • Symptom - Other
  • Specify - Asthma-like symptoms

4. How long did the symptoms last?

Unknown / Inconnu

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

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?

Unknown / Inconnu

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.)

In Feb 2022 on an unspecified date, the individual applied the product within their house to items such as a microphone, laptop, and a table surface. Following application of the product, the person developed shortness of breath, lung pain when breathing (respiratory pain), and asthma-like symptoms (dyspnea). Subsequently, the person cleaned the surfaces with apple cider vinegar as well as soap and water. Follow-ups for updates were unsuccessful. No further information is expected.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

The reported combination of symptoms: shortness of breath, lung pain and asthma like symptoms, may be indicative of a hypersensitivity reaction. While it was reported the symptoms occurred after product use the time to onset is unknown. Additionally, it is unknown if other differential diagnoses had been ruled out. When evaluating a patient for a potential allergic reaction, one must consider several potential environmental etiologies as well as any other new products, foods, beverages, personal care products, medications, or dietary supplements the patient had been using just prior to the onset of symptoms. It is unknown if symptoms resolved after the product was cleaned up or if a re-challenge occurred. The causality assessment is inconclusive due to the minimal information provided. 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.