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: 2007-4523

2. Registrant Information.

Registrant Reference Number: 182086

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-MAY-07

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

01-MAY-07

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. 24378      PMRA Submission No.       EPA Registration No.

Product Name: ROVRAL Flo Fungicide

  • Active Ingredient(s)
    • IPRODIONE

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: Pub. Area - Outdoor/Zone publique - ext

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

See main notes on subform II

To be determined by Registrant

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

Unknown

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

  • Eye
    • Symptom - Swollen eye
    • Symptom - Irritated eye
    • Symptom - Conjunctivitis

4. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 h

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)

Contact with treated area

Amount of time between application and contact 2

Hour(s) / Heure(s)

What was the activity? Golfing

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.

<=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.)

5/1/2007 Hx: Caller is MD treating a 32 year old male patient who presented to the clinic with swelling to the eyes. The patient was golfing and presumably had contact with vegetation that recently had diluted Rovral applied to it earlier this morning. After touching the vegetation or picking up a golf ball that had been sitting on the treated vegetation, they suspect that the patient may have rubbed his eyes resulting in the development of swelling about the eyes and conjunctivitis within 20 minutes. Patient has been given Benadryl at the facility and has had his eyes rinsed thoroughly with saline. Caller is not sure if eye exposure to this chemical occurred, but he is looking for information on the material. It is important to note that the three other individuals who were golfing with this patient have remained symptom free. Follow-up 5 hours after the initial call. Nurse states the patient was sent home after seemingly recovered. Patient was prescribed some steroidal antibiotic eye drops and was doing much better on his leaving the clinic.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.