Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-1118

2. Registrant Information.

Registrant Reference Number: 2009TH059

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

Address: 77 Belfied Road

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.

12-NOV-09

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

11-NOV-09

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. 25130      PMRA Submission No.       EPA Registration No.

Product Name: Advantage 10

• Active Ingredient(s)
  • IMIDACLOPRID

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

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.

Other

2. Demographic information of data subject

Sex: Male

Age: >6 <=12 yrs / > 6 < = 12 ans

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Hives

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?

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 18

Hour(s) / Heure(s)

What was the activity? affected person was cuddling dog to which advantage had been applied

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

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.

<=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.)

Mother reported incident. Mother applied advantage 10 to pet Nov 10 2009 around 10 pm. Her son was cuddling with the dog on the evening of Nov 11 2009. The mother feels the son developed hives within 30 minutes of contact with the dog. The hives affected his arms, neck and upper torso and then spread to his upper legs once he had a warm bath. The dog has not been bathed so the product will remain on the dog for at least 4 weeks. The son was taken to the doctor Nov 13 2009. He did not respond to benadryl and the doctor presribed cortisone cream. The son has not increased in weight from 24 kg in 18 months and the reason for his failure to gain weight and the hives is being investigated.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

The mother will provide additional information regarding her son's diagnosis as it becomes available.