Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4076

2. Registrant Information.

Registrant Reference Number: 2018EB051

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.

15-MAY-18

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

28-NOV-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)

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PMRA Registration No. 27583      PMRA Submission No.       EPA Registration No.

Product Name: advantageII medium dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PYRIPROXYFEN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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).

The patient is a x year old boy . Advantage II medium dog was applied on the dog (Havanese Poodle Cross).

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: Male

Age: >6 <=12 yrs / > 6 < = 12 ans

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Rash

4. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

Amount of time between application and contact 5

Hour(s) / Heure(s)

What was the activity? The patient waited 5 hours after the application before touching the dog.

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

11. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

12. Time between exposure and onset of symptoms.

>2 hrs <=8 hrs / > 2 h < = 8 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 patient is a x year old boy. Advantage II medium dog was applied on the dog (Havanese Poodle Cross). The patient waited 5 hours after the application before touching the dog. The patient developed an itchy rash on both of his hands. The patient washed their hands and they washed the product off the dog. On December 5th the patient had recovered.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

A - Probable Indirect product exposure occurred when the patient touched the dog. Affected site i.e. hands, is in line with the exposed site. Advantage contains benzyl alcohol which has mild irritant and paraesthetic properties which may have contributed to reported sign. Time to onset short and product may not have dried off when patient touched the treated dog. Overall, product relation is probable. Initial assessment confirmed by medical doctor.