Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-3293

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_002196

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-24

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

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)

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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 02Jul2024, the technician contacted Elanco via email to inquire about obtaining a replacement product and unintentionally reported a symptomatic human exposure to Advantage Multi 20 (Imidacloprid, Moxidectin) and K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen). The following was reported: On 01Oct2023, 01 Nov 2023 and 4Jun2024, a woman was accidentally indirectly exposed to 1 dose of Advantage Multi 20 (Imidacloprid, Moxidectin) via the topical route when her two dogs treated with the product sat on her lap. The product is not authorized for human treatment. From 15Oct2023 to 20Jun2024, the human was also accidentally indirectly exposed to 1 dose of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen), via the topical route when her two treated dogs sat on her lap. The product is not authorized for human treatment.

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.

Medical Professional

2. Demographic information of data subject

Sex: Female

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Itchy skin
  • Symptom - Rash
  • Symptom - Blister

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)

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.

Skin

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.)

On 01Oct2023, an unknown time after the Advantage Multi exposure, the 77 year old, 125 pounds, woman, with pre-existing medical history of high blood pressure, arthritis, autoimmune gum disease, and drug reaction, concomitantly on blood pressure medication and steroid cream for her gum disease, experienced an itchy rash and blistering on her lower abdomen and upper thighs. An unknown time after each application of the two products onto her two dogs, the human patient rash worsened before improving again. On an unknown date, the human patient began using a towel on her lap so that her dogs would not sit directly against her skin. On an unknown date, the human patientas signs were resolved. The human was examined by a physician on an unknown date. No treatment was done.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.