Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-0076

2. Registrant Information.

Registrant Reference Number: 3374457

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.

05-SEP-22

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

02-SEP-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 432-763

Product Name: Suspend SC

• Active Ingredient(s)
  • DELTAMETHRIN
    • Unknown

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7. b) Type of formulation.

Wettable or soluble powder

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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

Site: Res. - Out Home / Rés - à l'ext.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?

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: Female

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

3. List all symptoms, using the selections below.

System

• Cardiovascular System
  • Symptom - Chest pain

• Blood
  • Symptom - Other
  • Specify - Splenic aneurysm

• Respiratory System
  • Symptom - Other
  • Specify - Small pulmonary nodules
  • Symptom - Shortness of breath
  • Symptom - Difficulty Breathing

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)

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.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>24 hrs <=3 days / >24 h <=3 jours

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.)

9/5/2022 The caller reports that she applied the product which included spraying it overhead on 9/1/22. She experienced trouble breathing and chest pain that started on 9/2/22 at approximately 2200 hours. She visited the emergency room for her symptoms where she was given an IV Tordol and Iopamidol, no fluids, and multiple blood tests that included a complete blood count, metabolic panel, and troponin levels. She also had chest x-ray, chest CAT scan, and electrocardiogram. Lab work was determined to be normal, imaging showed small pulmonary nodules and splenic aneurysm. She was discharged home with oral Oxycodone and told to follow up with her cardiologist. She did not mention the product use to the emergency room doctor at the time. She reported that her symptoms were better but not resolved since visiting the emergency room. 9/6/2022 Follow up was attempted, but no further information could be gathered as the caller was unavailable.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

The described exposure would not be expected to result in the reported effects. While the symptoms started the following day after product exposure there is no plausible explanation for the product to produce or influence the reported symptoms. Other differential diagnoses have not been ruled out and while symptoms have improved they have not completely resolved. Symptoms after exposures like the one described are expected to result in minor self limiting symptoms and would not be expected to be ongoing in nature. The product is unlikely correlated to the reported effects.