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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-4973

2. Registrant Information.

Registrant Reference Number: 1-41396286

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.

27-JUL-15

5. Location of incident.

Country: UNITED STATES

Prov / State: ALABAMA

6. Date incident was first observed.

06-JUL-15

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. Unknown

Product Name: Sevin (non-specific)

  • Active Ingredient(s)
    • CARBARYL
      • Unknown

7. b) Type of formulation.

Liquid

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 for a detailed description regarding application.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

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: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Chills
    • Symptom - Fever
    • Symptom - Pain
  • Gastrointestinal System
    • Symptom - Weight loss

4. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

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.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

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.)

7/27/2015 12:48:52 PM - Sevin Concentrate - Hx: Caller states that 3 weeks ago, her husband mixed the product up with water but did so too strong. Her husband applied the product around the yard at that time. Since that time, her husband became ill and has lost about 25lb. Two weeks ago, he went to the doctor because his right side was hurting and he could not breath well. Her husband was prescribed an antibiotic for an infection. A week ago, he went back to the doctor because of excessive weight loss. They performed a CT scan but could not find anything. More recently, he has had a a fever, chills, and cannot eat. Today, he received another CT scan with NSF.Could it be the product?A: Inhalation during application should cause irritation of the eyes and upper respiratory tract as well as nausea, cough, headache, difficulty breathing, and shortness of breath.- I would not expect any of these sxs to develop1 week after application- Something else is going on

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.