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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2011-6137

2. Registrant Information.

Registrant Reference Number: 2011CP101US0043336

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.

14-OCT-11

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

30-JUN-11

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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: K9advantix 100

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %

7. b) Type of formulation.

Liquid

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?

Unknown

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: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

  • Gastrointestinal System
    • Symptom - Constipation
  • Cardiovascular System
    • Symptom - Abnormally low blood pressure
  • General
    • Symptom - Dehydration
  • Skin
    • Symptom - Itchy skin
  • General
    • Symptom - Sweating
  • Nervous and Muscular Systems
    • Symptom - Unconsciousness
    • Specify - passed out

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.

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

Unknown

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

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.

Unknown

11. What was the length of exposure?

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

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.)

product was applied to family dogs in the morning; dog owner arrived home late at night, was in a fight with his wife, became pruritic and sweaty, passed out and hit is head; was taken to hospital where he was diagnosed with constipation,low blood presure, and dehydration; he was put in IV fluids and was back to normal within 12 hours; unknown if owner has touched dogs at all since application

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

K9advantix may cause skin irritation and would not cause any systemic signs; unknow if owner did touch dog at all after treatment; sign sprobably unrelated