Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2307

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0017819 (Report 483253)

Registrant Name (Full Legal Name no abbreviations): Bayer inc

Address: 2920 Matheson Blvd

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

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

Human

4. Date registrant was first informed of the incident.

03-MAY-18

5. Location of incident.

Country: UNITED STATES

Prov / State: OKLAHOMA

6. Date incident was first observed.

03-MAY-18

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. 11556-145

Product Name: Tempo SC Ultra Spray

• Active Ingredient(s)
  • BETA-CYFLUTHRIN
    • Guarantee/concentration 11.8 %

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7. b) Type of formulation.

Other (specify)

Spray

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.

Other

2. Demographic information of data subject

Sex: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Cardiovascular System
  • Symptom - Fainting

• Nervous and Muscular Systems
  • Symptom - Difficulty talking

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)

Poisoning from ingestion of the pesticide

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.

Oral

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>30 min <=2 hrs / >30 min <=2 h

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.)

Approximately 45 minutes post ingestion, the individual fainted and experienced difficulty speaking. The individual was not examined by a physician and the symptoms continued. Due to the emergent nature of the communication, specific relevant event details were not obtained. Further attempts to obtain relevant details will be made.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

A - Probable Oral ingestion of product. Reported signs are consistent with the pharmaco-toxicological product profile. It is unknown why no medical care was sought. The time to onset is compatible. A product relation is considered likely. Initial causality assessment confirmed by medical doctor.