Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2628

2. Registrant Information.

Registrant Reference Number: 2018EB030

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-MAY-18

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

01-MAY-18

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. 29780      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII large dog

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

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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 human patient is an adult female. On May 1st, the pet owner applied K9 Advantix II large dog on her dog.

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: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Taste altered

4. How long did the symptoms last?

Unknown / Inconnu

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

What was the activity? At the moment of the application animal owner sneezed and accidentally got a small amount of the product on her lips.

Other

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?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

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 human patient is an adult female. On May 1st, the pet owner applied K9 Advantix II large dog on her dog. At the moment of the application she sneezed and accidentally got a small amount of the product on her lips. She does not think she got any of the product in her mouth. The pet owner immediately washed off her lips and rinsed out her mouth with salt water and chewed gum. The pet owner reports having a bad taste in her mouth that started after the accidental exposure and that is still present on May 2nd. The outcome is unknown.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

A - Probable Accidental indirect exposure. Contact with treated dog. Oral exposure with the product. Reported bad taste consistent with contact of the product with the mouth as the product does have a bitter flavored alcohol carrier. Consistent time to onset, duration seems long however. Even though the pet owner immediately washed off her lips and rinsed out her mouth with salt water and chewed gum, considering short time to onset and expected sign, a product connection is deemed to be probable.