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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-6223

2. Registrant Information.

Registrant Reference Number: 3325434

Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.

Address: 160 Quarry Park Boulevard SE Suite 130

City: CALGARY

Prov / State: AB

Country: Canada

Postal Code: T2C 3G3

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

12-JUL-22

5. Location of incident.

Country: CANADA

Prov / State: MANITOBA

6. Date incident was first observed.

12-JUL-22

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. 32824      PMRA Submission No.       EPA Registration No. Like EPA 264-861

Product Name: Prosaro XTR

  • Active Ingredient(s)
    • PROTHIOCONAZOLE
    • TEBUCONAZOLE

7. b) Type of formulation.

Application Information

8. Product was applied?

Unknown

9. Application Rate.

Unknown

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).

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: Male

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

3. List all symptoms, using the selections below.

System

  • Eye
    • Symptom - Irritated eye

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?

No

6. b) For how long?

7. Exposure scenario

Non-occupational

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

What was the activity? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity

Pesticide Spill

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.

Eye

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.)

7/12/2022 Caller was exposed to the product when it splashed into his eye. He has ocular irritation. He has removed his contact lenses and is rinsing his eyes at this time.7/13/2022 Attempted call back to the original caller. A message was left requesting follow up information.

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 can not 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.