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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-4683

2. Registrant Information.

Registrant Reference Number: 2012BS049

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.

31-AUG-12

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

31-AUG-12

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. 25132      PMRA Submission No.       EPA Registration No.

Product Name: Advantage 20

  • Active Ingredient(s)
    • IMIDACLOPRID

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

9.1

Units: %

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).

Owner applied 1 tube of Advantage 20 to her dog on Aug 30/2012 dorsal midline

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: Female

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

3. List all symptoms, using the selections below.

System

  • Skin
    • Symptom - Rash
    • Symptom - Itchy skin
    • Symptom - Blister

4. How long did the symptoms last?

Unknown / Inconnu

5. Was medical treatment provided? Provide details in question 13.

Unknown

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Non-occupational

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

Application

Contact with treated area

Amount of time between application and contact .25

Hour(s) / Heure(s)

What was the activity? treatment for pet

Drift from the application site

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?

>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.)

Pet owner has used this product on her dog for 3 years but always wears gloves when she applies the product. For the application on August 30/2012, the owner did not have gloves so applied product without them and did come in contact with the product. The owner has a history of allergies and sensitivity to chemicals. She washed her hands but noticed the next day she developed some blisters on the back of her hands, was itchy on extremities of body and developed a rash on arms, knees and face in the form of spots.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

It should be noted the owner has a history of allergies. It was recommended that she see her physician and supply doctor with the package for information. Offered to email the MSDS to pet owner but she did not have access to email. Left my contact information for her to update me on her progress