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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0480

2. Registrant Information.

Registrant Reference Number: 1-46300087

Registrant Name (Full Legal Name no abbreviations): Bayer CropScienc Inc

Address: Suite 200, 160 Quarry Park Blvd SE

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.

01-DEC-16

5. Location of incident.

Country: UNITED STATES

Prov / State: MISSOURI

6. Date incident was first observed.

17-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.       PMRA Submission No.       EPA Registration No. 264-334-71004

Product Name: Sevin Ready to Spray Bug Killer (non-specific)

  • Active Ingredient(s)
    • CARBARYL
      • Unknown

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: Grapes

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.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

  • Reproductive System
    • Symptom - Miscarriage

4. How long did the symptoms last?

>2 mos and <=6mos />2 mois et <=6mois

5. Was medical treatment provided? Provide details in question 13.

Yes

6. a) Was the person hospitalized?

Unknown

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

Other

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

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.

>3 days <=1 wk / >3 jours <=1 sem

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.)

11/17/2016 7:00:15 PM Sevin Ready to Spray Bug Killer (non-specific)EPA Reg: 264-334-71004Hx: Caller's husband used the product on grapes on the end of July 2016. Their daughter was pregnant at the time, and the husband gave the daughter two of the grapes he had sprayed the day before. The daughter had a miscarriage one week later. She also had another miscarriage this week. He is torn up about it thinking that the product on the grapes caused the miscarriages. Is it possible? A:There are no human reproductive studies; therefore we can not guarantee safety of exposure during pregnancy. However, transient incidental contact is not expected to be problematic. Please consult your physician for further recommendations.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.