Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0243

2. Registrant Information.

Registrant Reference Number: 2015CK339

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

Address: 2920 matheson BLVD

City: missisaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

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

Human

4. Date registrant was first informed of the incident.

16-NOV-15

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

16-NOV-15

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: advantix (unknown)

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN

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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 15-Nov-2015, a 13 year old boy, in unknown condition, with concomitant arthritis, was exposed to an unknown amount of Advantix (non - US Registered Product) (Imidacloprid - Permethrin) when he played with the dog who had the product applied, then touched his eye.

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: >12 <=19 yrs / >12 <=19 ans

3. List all symptoms, using the selections below.

System

• Eye
  • Symptom - Red eye
  • Symptom - Swollen eye

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? petting treated dog

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

Eye

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.)

Immediately post exposure, the individual had ocular redness and ocular swelling. The individual had not been evaluated by a physician and the clinical signs continued. No further information is expected. This case is closed. [Reason for use for product: Generic: Imidacloprid - Permethrin Brand: Advantix (non - US Registered Product) Reason: Secondary Exposure] [State of health: Unknown]

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.