Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-5322

2. Registrant Information.

Registrant Reference Number: 2018CP166

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.

20-JUN-18

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

20-JUN-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)

---

PMRA Registration No. 29779      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII 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).

On June 20 2018, a 36 kg kg, 2 year old male neutered canine cross was applied one tube K9advantixII extra large dog once topically by the owner;

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

• Nervous and Muscular Systems
  • Symptom - Numbness

4. How long did the symptoms last?

<=30 min / <=30 min

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)

Application

Drift from the application site

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.

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.)

a few minutes after application, the dog shook and the owner received some drops of K9advantix II in her mouth; the owner experienced numbness in her mouth for 10 minutes and then rinsed her mouth with water and recovered 5 minutes later.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

A - Probable Accidental direct exposure. Affected area compatible with exposed area. The patient probably experienced paresthesia induced by permethrin. Considering consistent time to onset, a product connection is probable. Preliminary assessment. Pending the final assessment after evaluation by Medical Doctor. If assessment is changed, the final statement will be submitted.