Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-3084

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2022_001175

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 1919 Minnesota Court, Suite 401

City: Mississauga

Prov / State: ON

Country: Canada

Postal Code: L5N 0C9

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

02-JUL-22

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

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.       PMRA Submission No.       EPA Registration No. Unknown

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 2 Jul 2022 Elanco Canada was made aware of symptomatic human exposure to Advantage II pipette size unknown (Imidacloprid, Pyriproxyfen), through a post made by the human patient on the Elanco Advantage ll Canada Facebook page. On an unknown date, an unknown amount of cats were administered Advantage II pipette size unknown topically by the owner.

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.

Data Subject

2. Demographic information of data subject

Sex: Unknown

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Other
  • Specify - unspecified allergic reaction

4. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

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)

Unknown

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

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 (sex, age, weight unknown) reported through a social media post that they were highly allergic to the product and could not be exposed to the cats for 2 days after application of the product to the cats. No further details were provided.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.