Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-2465

2. Registrant Information.

Registrant Reference Number: 2008CP005

Registrant Name (Full Legal Name no abbreviations): Bayer inc

Address: 77 Belfield Rd

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

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

Human

4. Date registrant was first informed of the incident.

14-MAY-08

5. Location of incident.

Country: UNITED STATES

Prov / State: OREGON

6. Date incident was first observed.

18-APR-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No.

Product Name: advantage

• Active Ingredient(s)
  • IMIDACLOPRID
    • Unknown

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

No

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

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

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.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Anaphylactic shock
  • Specify - anaphylactic reaction

• Skin
  • Symptom - Itchy skin
  • Specify - severe itching on hand

• Respiratory System
  • Symptom - Difficulty Breathing

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?

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

12. Time between exposure and onset of symptoms.

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

Caller applied advantage to her dogs(unknown size as it was dispensed in an unmarked syringe); she woke up 10 hours later experiencing severe itching on her hand; she had recently had hand surgery and had a small open wound on her hand. She began to have difficulty breathing and an ambulance was called. She was hospitalized following diagnosis of an anaphylactic reaction to an unknown product. She is wondering if perhaps the dog got on her bed at night and the dog became in contact with the open wound, causing the reaction.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.