Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-1787

2. Registrant Information.

Registrant Reference Number: 28385

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.

05-APR-19

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

02-APR-19

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. 29778      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II medium 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.

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).

On 1-Apr-2019, a 8 year old, 6.8 kg, female spayed Miniature Dachshund in good condition with no concomitant medical conditions was administered one K 9 ADVANTIX II 4 X 1.0 ML MED DOG, KP0DAKT/KP0D7NH (-), by Animal owner in one spot between the should blades

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: Male

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

3. List all symptoms, using the selections below.

System

• Nervous and Muscular Systems
  • Symptom - Headache

• Gastrointestinal System
  • Symptom - Diarrhea

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.

No

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Unknown

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

Contact with treated area

What was the activity? possibly skin contact with treated dog

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.

Unknown

11. What was the length of exposure?

<=15 min / <=15 min

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.)

Product was applied on dog 1-Apr-2019 by one owner. Another male family member pet the dog before bed time. Person was up at 4 am on 2-Apr-2019 with a headache. Went to the gym and experienced diarrhea for about 2 hours. Person returned to normal on 3-Apr-2019. This is not anticipated as a reaction to contact with a treated dog. Case linked to 28376

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.