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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-0793

2. Registrant Information.

Registrant Reference Number: 1429251

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

Address: 295 Henderson Drive

City: Regina

Prov / State: SK

Country: Canada

Postal Code: S4N 6C2

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

Human

4. Date registrant was first informed of the incident.

23-JUL-14

5. Location of incident.

Country: CANADA

Prov / State: MANITOBA

6. Date incident was first observed.

21-JUL-14

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. 29821      PMRA Submission No.       EPA Registration No.

Product Name: PROSARO 250 EC FUNGICIDE (CANADA)

  • Active Ingredient(s)
    • PROTHIOCONAZOLE
    • TEBUCONAZOLE

7. b) Type of formulation.

Application Information

8. Product was applied?

No

9. Application Rate.

Unknown

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: Male

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

3. List all symptoms, using the selections below.

System

  • Nervous and Muscular Systems
    • Symptom - Numbness

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?

Unknown

7. Exposure scenario

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

Pesticide Spill

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)

None

10. Route(s) of exposure.

Oral

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

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

7/23/2014 Caller was diluting the product in a sprayer about 36 hours ago, when it splashed out into his mouth. He rinsed his mouth. Several hours later, he had some numbness in his mouth. This worsened yesterday, and now he has numbness in his mouth, on his lips, and on his tongue.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.