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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-7930

2. Registrant Information.

Registrant Reference Number: 2017RB171

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.

16-SEP-17

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

12-SEP-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).

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.

Data Subject

2. Demographic information of data subject

Sex: Male

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

  • Gastrointestinal System
    • Symptom - Mouth Irritation
  • Skin
    • Symptom - Blister
    • Specify - white blisters on the inside of the cheek

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)

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.

Oral

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.)

On 12-Sep-2017, a (age) year old, man, in unknown condition, with concomitant medical conditions of type II diabetes, rheumatoid arthritis and osteoarthritis, was exposed to an unknown amount of Advantix (non - US Registered Product) (Imidacloprid - Permethrin) when he got the product on his hands, while he applied it to his dog, and then touched his mouth. Immediately post exposure, the individual flushed the inside of the mouth with water, milk and juice. Approximately 30 minutes post exposure, the individual experienced an oral irritation and white blisters on the inside of the cheek. The individual was not examined by a physician and the clinical signs continued. [Reason for use for product: Generic: Imidacloprid - Permethrin Brand: Advantix (non - US Registered Product) Reason: Secondary Exposure] [State of health: Unknown] On September 18, 2017 Dr (name) called the individual and confirmed he recovered 2 days after the incident occurred, and confirmed the product that was involved.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.