Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-5726

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2023_034477

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.

05-JUL-23

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

Unknown

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. Unknown

Product Name: Advantage II pipette size unknown

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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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.

Liquid

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 05-Jul-2023, Elanco was contacted by an animal owner regarding an efficacy concern and adverse reaction with Seresto Cat Collar and Advantage II pipette size unknown on a feline and reported the following: On an unknown date in 2022, a cat had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner for flea control. On 24 Jan 2023 the cat had another Seresto cat collar applied. On approximately 24 Mar 2023, 1 tube Advantage II pipette size unknown was applied to the cat. The Seresto cat collar was used correctly; appropriate use of Advantage II is unknown.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

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 - Parasitism

• Skin
  • Symptom - Pruritus

• 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 an unknown date, the male cat, of unknown signalment, in unknown condition, with no known concomitant medical conditions, developed generalized pruritus, and live fleas were found on the cat. The cat was bathed approximately once a month with a liquid dish soap. On approximately 24-Mar-2023, the cat developed generalized pruritus, and live fleas (about 2/time) were found on the cat. The yard was treated. The cat occasionally swam and was indoors only. On approximately 25-Mar-2023, live fleas continued to be found on the cat. The cat was not examined by the veterinarian, no treatments were performed, and the clinical sign and fleas continued. On approximately 01-Jun-2023, the cat died. 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