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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-4722

2. Registrant Information.

Registrant Reference Number: 1882596

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

Address: 160 QUARRY PARK BLVD. SE Suite 200

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.

09-AUG-16

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

26-JUL-16

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. 28532      PMRA Submission No.       EPA Registration No.

Product Name: IGNITE HERBICIDE (Canada)

  • Active Ingredient(s)
    • GLUFOSINATE AMMONIUM

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: Unknown crops

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.

Medical Professional

2. Demographic information of data subject

Sex: Male

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

3. List all symptoms, using the selections below.

System

  • Blood
    • Symptom - Hemolysis
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - Abnormal brain function
    • Symptom - Other
    • Specify - Delirium

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?

Yes

6. b) For how long?

10

Day(s) / Jour(s)

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)

Unknown

10. Route(s) of exposure.

Skin

Respiratory

11. What was the length of exposure?

<=15 min / <=15 min

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.)

8/9/2016 Caller is a physician treating a patient that was admitted at a local hospital for a period of 10 days a few weeks ago following a suspected exposure to the product. Patient was spraying crops with the product from an unspecified device when the machine stopped working. He attempted to fix the machine and inhaled the product and got it on unprotected skin. It is unknown if any personal protective equipment was worn at the time. At some point following this event, he was seen at a hospital and admitted for delirium, hemolysis, and abnormal brain function. Caller does not have medical records from the intensive care unit where patient was treated. It is not known if product was involved in the illness reported.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.