Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-6598

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2021_040736

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 150 Research Lane, Suite 120

City: Guelph

Prov / State: ON

Country: Canada

Postal Code: N1G 4T2

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

05-DEC-21

5. Location of incident.

Country: UNITED STATES

Prov / State: MISSOURI

6. Date incident was first observed.

01-DEC-21

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.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto Cat Collar

• Active Ingredient(s)
  • FLUMETHRIN
    • Guarantee/concentration 4.5 %
  • IMIDACLOPRID
    • Guarantee/concentration 10 %

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7. b) Type of formulation.

Other (specify)

collar

Application Information

8. Product was applied?

Yes

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

To be determined by Registrant

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

Unknown

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

• Skin
  • Symptom - Pruritus

• Respiratory System
  • Symptom - Difficulty Breathing

• Skin
  • Symptom - Itchy skin

4. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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)

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.

Unknown

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 05-Dec-2021, an animal owner contacted Elanco regarding possible human exposure involving Seresto Cat and reported following: On approximately 28-Nov-2021, a cat of unknown signalment with unknown medical condition was applied Seresto cat (Flumethrin-Imidacloprid) around neck via the topical route by owner. Since approximately 01-Dec-2021, the 70 year old, 68.03 kg, female cat owner with concomitant medical conditions of allergies to honey, lavender, mint, coconut, iodopropynyl carbamate, and 2-hydroxyethyl methacrylate, pseudocholne esterse deficiency, hypertension, hypothyroid, and possible asthma , was accidentally exposed to Seresto Cat and reported having itchy face. She treated this with steroid cream with some relief. The owner concomitantly takes levothyroxine, biotin, calcium, spirolactone, krill oil, pravastatin, montelukast, nasal spray. On 04-Dec-2021, night, every time her cat jumped into bed with her, she had difficulty breathing. This resolved when she was away from the cat. Update: 08 Dec 2021 The animal owner stated that her difficulty breathing has resolved with the removal of a basket that was next to her bed that contained some chemicals she was allergic to. Her cat continues to wear the Seresto collar and the animal owner has had no further difficulty breathing or facial itching symptoms.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.