Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2225

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2024_010206

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.

13-MAR-24

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

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)

---

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

Product Name: Seresto Small Dog Collar

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

---

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 13-Mar-2024, Elanco was contacted by an animal owner who inadvertently reported the following adverse event and extra label use of a Seresto Small Dog (Flumethrin-Imidacloprid) collar. The intent of the call was to inquire about expiration dates on Seresto collars, and to verify that a collar was authentic. On an unknown date in approximately 2019, a dog had a Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner. Collar was not used as per label (misuse: underdose).

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Spaniel - King Charles Cavalier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

11.33

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Seizure

• Cardiovascular System
  • Symptom - Other
  • Specify - Heart failure

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

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

Approximately 30 minutes after collar application, the 9 year old,11.33 Kg, male, Spaniel - King Charles Cavalier dog, experienced an epileptic seizure of short duration. The dog was not evaluated by a veterinarian and no treatment was performed. The clinical sign resolved. The collar was removed. On an unknown date in approximately 2020, the dog was diagnosed with moderate heart failure. This was an incidental finding. The caller did not allege that the heart condition was caused by the collar. On an unknown date in late 2023, the dog died.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here