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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-6313

2. Registrant Information.

Registrant Reference Number: 2017CK048

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

Address: 2920 matheson BLVD

City: Mississaugua

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.

02-JUN-17

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

15-MAY-17

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)

PMRA Registration No. 29779      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II extra large dog

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN
    • PYRIPROXYFEN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

4

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).

a pet owner applied 1 tube of k9 advantix II XL to her dog on may 15th

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

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: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

  • Skin
    • Symptom - Erythema
    • Symptom - Tingling skin

4. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 h

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)

Other

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

11. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

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.)

The same day of application, the pet owner noticed redness on her face and facial stinging when she was near to her dog. the signs would resolve when the pet owner was away from her dog. No treatment was required and advice from a medical professional was not sought after.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.