Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4814

2. Registrant Information.

Registrant Reference Number: 370895

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

Address: Suite 100, 3131 114 Avenue SE

City: Calgary

Prov / State: AB

Country: Canada

Postal Code: T2Z 3X2

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

01-SEP-08

5. Location of incident.

Country: UNITED STATES

Prov / State: HAWAII

6. Date incident was first observed.

01-SEP-08

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. 432-1363

Product Name: Tempo SC Ultra

  • Active Ingredient(s)
    • CYFLUTHRIN
      • Guarantee/concentration 11.8 %

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: Animal / Usage sur un animal domestique

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.

Medical Professional

2. Demographic information of data subject

Sex: Male

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Cardiovascular System
    • Symptom - Arrhythmia
    • Symptom - Bradycardia
    • Symptom - Arrhythmia
    • Specify - Third Degree Heart Block
  • General
    • Symptom - Malaise

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

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)

None

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

>2 hrs <=8 hrs / > 2 h < = 8 h

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.)

9/1/2008 Caller is doctor treating a patient in the emergency room. The patient applied the product at unknown concentration to the dog with bare hands three hours ago. The patient presented feeling ill, and an electrocardiogram revealed that patient has a third degree heart block. The patient responded well to atropine, and is being sent to intensive care for formal cardiac work up and additional testing. The patient had a prior history of heart disease long before the recent use of Tempo. Physician indicated that he does not believe the current heart condition was caused by the Tempo.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.