Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0665

2. Registrant Information.

Registrant Reference Number: 2013CK109

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.

11-JAN-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

05-JAN-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. 25129      PMRA Submission No.       EPA Registration No.

Product Name: advantage 18

• Active Ingredient(s)
  • IMIDACLOPRID

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

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 05-Jan-2013, a male, human, in good condition, with no known concomitant medical conditions, was exposed to an unknown amount of Advantage 18 Topical Solution (Imidacloprid) once while petting the dog after the product was applied and he got the product on his hands and then chewed on a hang nail.

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.

Other

2. Demographic information of data subject

Sex: Male

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Diarrhea

4. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

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 a dog treated with Advantage 18

Poisoning from ingestion of the pesticide

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

Oral

11. What was the length of exposure?

Unknown / Inconnu

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.)

Approximately 12 hours post exposure the patient developed diarrhea. The patient was not examined or treated by a physician. All symptoms resolved on 08-Jan-2013 with out medical intervention. Approximately 12 hours post exposure the patient developed diarrhea. The patient was not examined or treated by a physician. All symptoms resolved on 08-Jan-2013 with out medical intervention. Update: 2013-01-17. All symptoms resolved on 08-Jan-2013 with out medical intervention. No further information is expected. This case is closed

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.