Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0097

2. Registrant Information.

Registrant Reference Number: 2013CK146

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.

16-AUG-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

09-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. 27660      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix 55

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

Units: mL

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 09-Aug-2013, a 54 year old, unknown weight, female, human, in good condition, with no known concomitant medical condition, was exposed to an unknown amount of K9 Advantix 55 (Imidacloprid - Permethrin) after treating her dog and putting her hands on her mouth and tasting the 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: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Nervous and Muscular Systems
  • Symptom - Headache
  • Symptom - Dizziness

• Gastrointestinal System
  • Symptom - Nausea

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)

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

Oral

11. What was the length of exposure?

Unknown / Inconnu

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.)

Immediately after exposure the human had nausea, dizzness and headache. Note: The patient made a complete recovery without treatment.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

GDS comment: Accidental indirect exposure - Contact with treated dog with confirmed subsequent oral exposure (hand to mouth contact). Nausea may be expected after accidental oral exposure, as a reaction to the bitter flavored alcohol carrier in the product. Headache and dizziness usually not expected. However, onset time and chronology are very short but compatible. Thus, a product connection is deemed to be possible. Initial assessment confirmed by medical doctor