Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-6786
2. Registrant Information.
Registrant Reference Number: 3654537
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.
08-JUL-23
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
08-JUL-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)
PMRA Registration No. 33398
PMRA Submission No.
EPA Registration No.
Product Name: ROUNDUP ADVANCED READY-TO-USE PUMP `N GO
7. b) Type of formulation.
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).
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: >19 <=64 yrs / >19 <=64 ans
3. List all symptoms, using the selections below.
System
- Eye
- Symptom - Conjunctivitis
- Symptom - Red eye
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)
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
Other
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.
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.)
7/8/2023 Caller states that 25 minutes ago she was setting down the product and accidentally sprayed herself in the right eye. She states she has been blinking into a cup of water for 15 minutes to attempt to rinse her eye and she does not wear contact lenses. She states her eye is red. 7/10/2023 Attempted callback to consumer. No answer. No voice mail. Unable to leave message.
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.