Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0108

2. Registrant Information.

Registrant Reference Number: 2013CK158

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.

26-OCT-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

02-AUG-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)

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

Product Name: Advantage (unknown size)

• Active Ingredient(s)
  • IMIDACLOPRID

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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: 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).

On approximately 01-Aug-2013, a female, human, of unknown signalment, in unknown condition with no known concomitant medical conditions, was exposed to an unknown amount of Advantage (dog-unspecified) (Imidacloprid) after petting her dog and touching wet product

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.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Nausea

• Nervous and Muscular Systems
  • Symptom - Dizziness

4. How long did the symptoms last?

Unknown / Inconnu

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

No

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

What was the activity? Contact with treated pet

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

Unknown

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.

Unknown / Inconnu

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.)

An unknown amount of time post exposure, the female exhibited dizziness and felt sick.Approximately 2 days after the onset, the clinical signs resolved. The female was not seen by a physician and no known medical treatments were provided

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

Accidental indirect topical exposure. Reported signs are not expected after indirect topical exposure as inconsistent with the pharmaco-toxicological product profile. Time to onset and time line unknown, however product exposure took place. Finally, product involvement considered to be not assessable