Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-0818

2. Registrant Information.

Registrant Reference Number: 2023-US-001675

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.

23-JAN-23

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

01-JAN-20

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: Zodiac Fleatrol Fogger

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

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7. b) Type of formulation.

Other (specify)

Aerosol

Application Information

8. Product was applied?

No

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

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

• Eye
  • Symptom - Permanent change in vision

• Respiratory System
  • Symptom - Other
  • Specify - Respiratory problem not otherwise specified

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?

No

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?

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.)

On approximately 01 Jan 2020, a person with no known concomitant medical conditions, was possibly exposed to an unknown amount of Zodiac Fleatrol Fogger via an unknown route. No specific exposure was described the product was purchased on approximately 01 Jan 2020 and placed on a shelf in the home for storage. On approximately 01 Jan 2022, the person developed decreased vision and an unspecified respiratory problem. The person was evaluated by a physician and prescribed eyeglasses. No other treatments were specified. On approximately 01 Oct 2022, her vision continued to worsen. The person was re-evaluated by a physician and her eyeglass prescription was adjusted. No other treatments were specified. On 23 Jan 2023, the person noticed the product on the shelf and stated that it was moist and possibly leaking. No specific exposure was reported. The vision changes persist. No further information was received.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Assessment: Given the described exposure the signs and symptoms are not likely correlated with the product. A temporal relationship does not exist as there was no known ocular exposure to the product and symptoms started approximately two years after the product was stored in the house. The pharmacologic/toxicologic picture does not fit with the described possible exposure to the product and all other differential diagnoses have not been ruled out and should be explored. 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.