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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-6228

2. Registrant Information.

Registrant Reference Number: 3333285

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.

21-JUL-22

5. Location of incident.

Country: CANADA

Prov / State: MANITOBA

6. Date incident was first observed.

21-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. 34093      PMRA Submission No.       EPA Registration No.

Product Name: PROSARO PRO FUNGICIDE

  • Active Ingredient(s)
    • FLUOPYRAM
    • PROTHIOCONAZOLE
    • TEBUCONAZOLE

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: Agricultural-Outdoor/Agricole-extérieur

Préciser le type: Farm

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?

Yes

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

  • Skin
    • Symptom - Other
    • Specify - Skin warm

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

Occupational

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

Application

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

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.

Skin

11. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

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.)

7/21/2022 Caller is a farmer and was applying the product at the farm 1 hour ago. Some of the diluted solution sprayed out and onto his arm, pants, and legs. Caller is just leaving the farm to go home, remove the affected clothing, and shower. His skin feels slightly warm, but denies any other symptoms. Caller is driving and wants to get home to shower, and will call back. Call back from the original caller. He was able to shower and change his clothes. He is currently back working outdoors and his skin is warm, but caller says it is hot outside and this may be causing the warm feeling.

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.