Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-2818

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2022_001022

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.

13-JUN-22

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

13-JUN-22

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?

Yes

9. Application Rate.

.8

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 13-Jun-2022, a human patient contacted Elanco regarding accidental secondary exposure to Advantage II Large Cat (Imidacloprid, Pyriproxyfen). On 13 Jun 2022 the patient administered a tube of Advantage ll Large Cat to her cat. After administration, the human patient kissed the cat.

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

• Gastrointestinal System
  • Symptom - Dry throat

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? Kissing the cat

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 <=2 hrs / >30 min <=2 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.)

The 45 year old, 67 kg, female, human, with pre-existing medical conditions of high blood pressure, two mechanical heart valves and hypothyroidism, reported taking the concomitant medications warfarin, synthroid, metoprolol, telmisartan, indapamide, rosuvastatin, and baby acetylsalicylic acid for the pre-existing conditions. After administration of the Advantage II to the cat, the human patient kissed the cat. One hour after kissing the cat, her throat became dry for about 6 hours. On 14 Jun 2022 the human patient reported she was completely recovered without treatment.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.