Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2299

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2024_012128

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.

Domestic Animal

4. Date registrant was first informed of the incident.

26-MAR-24

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

26-MAR-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-191

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.

1

Other Units: collar

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 26 Mar 2024, an animal owner contacted Elanco for a potential adverse event involving a Seresto Cat collar on a feline and reported the following: On 26 Feb 2024, a feline had a Seresto Cat (Imidacloprid, Flumethrin) collar placed around the neck by the animal owner. No concomitant products were administered.

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic mediumhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Stiffness

• Cardiovascular System
  • Symptom - Bradycardia

• Respiratory System
  • Symptom - Dyspnea

• Skin
  • Symptom - Other
  • Specify - Low skin temperature

• General
  • Symptom - Hesitancy to move
  • Specify - Unable to move

• Respiratory System
  • Symptom - Shortness of breath

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On 25 Mar 2024, the 13-year-old, unknown weight, female/neutered, Domestic Medium hair feline in unknown condition, with no known concomitant medical conditions, was bathed in an unknown shampoo. On 26 Mar 2024, the cat was not moving, cold to the touch, had stiff muscles, a faint heart rate and shallow breathing. The cat has not been examined at the time of the call. The cat died at home of unknown causes at home before getting her to the vet. The cat was not examined, owner did not take her at all and no necropsy was performed.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here