Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-1543

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2024_006382

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.

20-FEB-24

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

18-FEB-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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PMRA Registration No.       PMRA Submission No.       EPA Registration No.

Product Name: PERMETHRIN HOME SPRAY (UNSPECIFIED FORMULATION)

• Active Ingredient(s)
  • PERMETHRIN

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

Product Name: PEPPERMINT (UNSPECIFIED FORMULATION)

• Active Ingredient(s)
  • PEPPERMINT

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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 20Feb2024, an animal owner contacted Elanco regarding a possible adverse event with using Seresto Cat (Imidacloprid, Flumethrin) and reported the following: On 16Feb2024, a feline was shaved and flea bathed by a groomer using dawn dish soap and an unknown de-flea shampoo. The feline then had 1 Seresto Cat (Imidacloprid, Flumethrin) collar placed around his neck by the animal owner. The feline was secondarily exposed to an unknown permethrin home spray and an unknown peppermint spray the animal owner used within the home.

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

Himalayan

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• General
  • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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 18Feb2024, the 10-year-old of unknown weight, neutered, male, Himalayan feline/cat, in unknown condition, with fleas, a history of urinary tract infections with crystals, unspecified gastrointestinal issues, and with mass on his gums that was removed in approximately Aug2023, was found deceased on the couch. A necropsy had not been 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