Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-3677

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_001390

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-JUL-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

11-JUL-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)

---

PMRA Registration No. 29779      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Extra Large 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 Jul 2023, Elanco was made aware of a human exposure to K9 advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen). On 11 Jul 2023, the human patient kissed his dog where K9 advantix II Extra Large Dog had recently been applied.

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: Male

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

3. List all symptoms, using the selections below.

System

• Nervous and Muscular Systems
  • Symptom - Numbness

4. How long did the symptoms last?

>2 hrs <=8 hrs / > 2 h < = 8 h

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)

Contact with treated area

What was the activity? Kissed the dog at the application site

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.

Oral

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.)

Within 2 minutes of kissing the dog, the 57 year old, 104 pounds, male human, with pre-existing hypertension, who takes an unspecified blood thinner, experienced numbness of the tongue, mouth and nose. Treatment consisted of rinsing the mouth with water. The patient took a shower and signs resolved after a few hours.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.