Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-1643

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_00967

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.

11-APR-24

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

10-APR-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)

---

PMRA Registration No. 29777      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Small Dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN
  • PYRIPROXYFEN

---

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

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 11 Apr 2024, a pet owner contacted Elanco to report a symptomatic human exposure of herself following application of K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) and reported the following: On 10 Apr 2024, the pet owner applied 1 dose of K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) to her dog, and was accidentally exposed to the product via inhalation. The pet owner was also taking hypertension medication.

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: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• Nervous and Muscular Systems
  • Symptom - Headache
  • Symptom - Numbness

4. How long did the symptoms last?

Unknown / Inconnu

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)

Application

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.

Respiratory

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 10 Apr 2024, immediately after treating her dog, the [Age] year old, [Weight] kilograms, female human, with a medical history of allergies to acetone, sensitivity to fragrances and bounce dryer sheets, and chronic hypertension, exhibited numbness of the lips and tongue and headache. It is unknown if the pet owner was examined by a physician. No treatment was done. The headache resolved 2 hours after onset. On 11 Apr 2024, in the evening, the pet owner had recovered from the numbness.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.