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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-3978

2. Registrant Information.

Registrant Reference Number: 667977

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

Address: #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.

26-JUL-10

5. Location of incident.

Country: UNITED STATES

Prov / State: MISSISSIPPI

6. Date incident was first observed.

16-JUL-10

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. 264-779

Product Name: Stratego Fungicide

  • Active Ingredient(s)
    • PROPICONAZOLE
      • Guarantee/concentration 11.4 %
    • TRIFLOXYSTROBIN (CGA 279202)
      • Guarantee/concentration 11.4 %

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: Agricultural-Outdoor/Agricole-extérieur

Préciser le type: Unknown

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

  • Respiratory System
    • Symptom - Pulmonary edema
    • Symptom - Other
    • Specify - Decreased oxygen saturation
    • Symptom - Coughing up blood
  • Cardiovascular System
    • Symptom - Other
    • Specify - aortic stenosis
  • General
    • Symptom - Other
    • Specify - infection

4. How long did the symptoms last?

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

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

5

Day(s) / Jour(s)

7. Exposure scenario

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)

None

10. Route(s) of exposure.

Unknown

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.)

7/26/2010 12:00:44 PM Physician is calling from the medical college after they had been consulted regarding this patient and they wanted to insure that they sought additional product information before finalizing their impresssions. The physician had somewhat limited information about the use scenario involving the product other than the fact that the individual had been routinely spraying it with others approximately 10 days ago. Pt is a (age) yr old gentleman with a long history of multiple cardiovascular medical problems and was on multiple medications prior to this incident. He presented to a local hospital on 7/21/2010 with hemoptysis that developed 5 days post spraying the product with 4 other co-workers. None of the individuals working with the product reported any known exposure. No PPE was worn. None of the individuals including this patient experienced any adverse effects at the time the product was used. During his initial workup, he had reported using the product 5 days earlier and the treating physicians just wanted to rule out any potential involvement of the fungicide. Their diagnosis was aortic stenosis with complication of pulmonary edema and potentially an infectious etiology. After admission to the hospital the patient was treated with antibiotics and steroids, he has improved and is scheduled to be released.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.