Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2899

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2024_013798

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.

04-APR-24

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

6. Date incident was first observed.

04-APR-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 04Apr2024, an animal owner contacted Elanco via phone call intending to report an Adverse Event with use of Seresto Cat (Imidacloprid, Flumethrin) in a feline. On 04Apr2024, one Seresto Cat (Imidacloprid, Flumethrin) collar was placed around the neck of a cat by the animal owner for flea and tick prevention. The product was used correctly. The pet owner reported that she had been using Seresto collar for several unspecified years. 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 Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

8.2

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death

• Cardiovascular System
  • Symptom - Other
  • Specify - Cardiomyopathy

• Gastrointestinal System
  • Symptom - Fecal incontinence
  • Symptom - Drooling

• General
  • Symptom - Vocalizing

• Respiratory System
  • Symptom - Other
  • Specify - Microscopic lesions on lungs

• Cardiovascular System
  • Symptom - Other
  • Specify - Microscopic lesions on heart

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

One hour post application of the collar applied on 04 Apr 2024, the 7 year old, 8.2 kg, neutered, male, Domestic Shorthair feline, in unknown condition, with no known concurrent medical conditions, exhibited vocalization, drooling and defecation. The cat died. The feline was examined by a veterinarian. On 17Apr2024, a necropsy was performed on the cat and microscopic lesions in the lungs and heart were identified. The cause of death was determined to be feline idiopathic hypertrophic cardiomyopathy.

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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