Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-2889

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2023_017401

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.

19-APR-23

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

01-APR-23

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 Collar unknown

• 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 19 Apr 2023, an animal owner contacted Elanco regarding adverse event involving Seresto collar unknown on a dog. On 04 Mar 2023, a dog had 1 Seresto Collar unknown (Imidacloprid, Flumethrin) placed around the neck via the topical route by the animal owner for flea control. It was unknown if the product was used correctly. It was unknown if any concomitants were administered.

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

Dog / Chien

3. Breed

Dachshund

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 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

• Respiratory System
  • Symptom - Heavy breathing

• Cardiovascular System
  • Symptom - Other
  • Specify - Congestive heart failure

12. How long did the symptoms last?

Persisted until death

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

Yes

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

Approximately on 01 Apr 2023, the 12 year old, of unknown weight, neutered, male, Dachshund (Unspecified) dog, in unknown condition, with unknown concomitant medical conditions, was found to have congestive heart failure. The pet was put on furosemide and enalapril to treat the problem. On 17 Apr 2023, the pet started breathing heavier. The collar was removed by the pet owner on 19 Apr 2023. On 21 Apr 2023, the owner took the dog to the attending veterinarian for a furosemide injection and the dog passed away shortly after at home.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here