Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-6014

2. Registrant Information.

Registrant Reference Number: 35106

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.

30-NOV-20

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

23-NOV-20

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. 27583      PMRA Submission No.       EPA Registration No.

Product Name: advantage II Pipette size unknown

• Active Ingredient(s)
  • IMIDACLOPRID
  • PYRIPROXYFEN

---

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 21-Nov-2020, a dog of unknown age, weight, and reproductive status, in unknown condition with no concomitant medical conditions was administered one ADVANTAGE II 6 X 1.0 pipette size unknown, (-), by Animal owner. The product was used according to label (Unknown).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

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: Female

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

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Hives

4. How long did the symptoms last?

Unknown / Inconnu

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

24

Hour(s) / Heure(s)

7. Exposure scenario

Unknown

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

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>24 hrs <=3 days / >24 h <=3 jours

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.)

On 23-Nov-2020, a 7 year old female child that lives with the treated dog, developed hives. On 23-Nov-2020 the 7 year old child was administered an epipen by a school staff member. On 23-Nov-2020 the 7 year old child was hospitalized for 24 hours. On 27-Nov-2020 the 7 year old child developed hives again. The outcome is unknown.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.