Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-6257

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_002528

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.

25-OCT-23

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

25-OCT-23

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. 27586      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II Large Cat

• Active Ingredient(s)
  • IMIDACLOPRID
  • PYRIPROXYFEN

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7. b) Type of formulation.

Application Information

8. Product was applied?

No

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

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: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Eye
  • Symptom - Burning eye

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)

Other

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.

<=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.)

On 25 Oct 2023, the human patient who is a female of unknown weight and age, with unknown concomitant medical condition was accidentally exposed to Advantage II Large Cat (Imidacloprid, Pyriproxyfen). The patient reported that she opened the tube and inadvertently squeezed on the tube. The product squirted onto her sweater and pants. The patient did not report exposure of her hands however she washed them immediately. The patient then reported that 30 minutes after the incident, her eyes were burning. The patient rinsed her eyes and recovered 30 minutes after onset.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.