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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4826

2. Registrant Information.

Registrant Reference Number: 2081318

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.

25-JUL-17

5. Location of incident.

Country: CANADA

Prov / State: SASKATCHEWAN

6. Date incident was first observed.

Unknown

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?

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.

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

  • Cardiovascular System
    • Symptom - Hypertension
  • Gastrointestinal System
    • Symptom - Diarrhea
    • Symptom - Nausea
  • Nervous and Muscular Systems
    • Symptom - Dizziness
  • Skin
    • Symptom - Irritated skin
    • Symptom - Itchy skin

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?

Unknown

7. Exposure scenario

Non-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

Drift from the application site

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

11. What was the length of exposure?

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

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.)

7/25/2017 Caller reports that his motorcycle stalled on a road on 7/15/2017 and he was unable to start it. He was sprayed by a crop duster plane while on the road. The product was diluted, and came into contact with his left arm. The product was on his skin for approximately 30 minutes before he was able to shower. On 7/16/2017 he developed nausea, dizziness, and diarrhea. These symptoms remain today. Earlier today he went to the hospital, and had blood and urine tests completed. His blood pressure was elevated while at the hospital, but the values are unknown and he was not given any medication to manage the issue. He was prescribed metacloprimide, and sent home within a few hours. His doctor thought the symptoms may be viral. 7/27/2017 Call back from the original caller. Caller additionally reports that on 7/15/2017 in the evening he also experienced burning and itching on the arm that was thought to have been sprayed with the product. Those symptoms resolved within 12 hours or less. The other effects appear to be resolving over time.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.