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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-5327

2. Registrant Information.

Registrant Reference Number: 1219934

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.

03-AUG-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

21-JUL-13

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. 17734      PMRA Submission No.       EPA Registration No.

Product Name: DECIS 5 EC INSECTICIDE (Canada)

  • Active Ingredient(s)
    • DELTAMETHRIN

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: Fruit farm

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?

No

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Male

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Eye
    • Symptom - Red eye
    • Symptom - Irritated eye
  • Nervous and Muscular Systems
    • Symptom - Muscle pain
    • Symptom - Muscle weakness
  • Cardiovascular System
    • Symptom - Stroke
  • Nervous and Muscular Systems
    • Symptom - Slurred speech
  • Eye
    • Symptom - Other
    • Specify - Visual disturbance

4. How long did the symptoms last?

Unknown / Inconnu

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

Unknown

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.

Skin

Eye

11. What was the length of exposure?

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

12. Time between exposure and onset of symptoms.

<=30 min / <=30 min

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.)

8/3/2013 Caller's husband sprayed product outdoors on their fruit farm on 7/21/13, and during application he got product in his eye and experienced eye redness and irritation. He sprayed the product again on 7/25/13, at which time diluted product splashed onto his head, shoulders, and back. Some time later while he was driving a tractor he developed slurred speech, muscle weakness, and vision disturbance in his left eye. He was taken to the hospital where he was diagnosed with what the caller described as two 'mini-strokes', and currently remains hospitalized. He is now complaining of muscle soreness in his shoulder. Follow-up with the patient's wife was completed on 8/6/2013. The wife states that her husband is still in the hospital being treated for stroke. He has been in the hospital since the beginning of August.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.