Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-3280

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_002248

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.

07-JUL-24

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

06-JUL-24

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 07 Jul 2024, a woman contacted Elanco via SafetyCall regarding an accidental ocular exposure to K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen). The following was reported: On 05 Jul 2024, the female human patient reported accidental ocular exposure to K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) after another human had applied the product to their dog. The dog moved after application and the human female felt 1 dose of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) contact her eye. The eye was not rinsed at that time.

To be determined by Registrant

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

No

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

3. List all symptoms, using the selections below.

System

• Eye
  • Symptom - Pain

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)

Other

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.

Eye

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>8 hrs <=24 hrs / > 8 h < = 24 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.)

On the morning of 06 Jul 2024, the 25 year old, 47.73 kilogram, female human with no known concomitant medical conditions, and that does not wear contact lenses, rinsed the eye briefly as the eye was uncomfortable (Eye pain). On 08 Jul 2024, a follow up call for the human female patient was unsuccessful, and at the time of reporting the outcome of the patient was unknown and it was unknown if any additional treatment was pursued.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.