Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2904

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2024_016436;

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.

18-APR-24

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

6. Date incident was first observed.

16-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)

---

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 18-Apr-2024, Elanco was contacted by an animal owner who reported the following adverse event when using a Seresto Small Dog (Flumethrin-Imidacloprid) collar. On approximately 08-Apr-2024, the animal owner placed the Seresto Small Dog (Flumethrin-Imidacloprid) collar around the neck of the dog for flea control. This was the first use of the product and it was used according to the label.

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

Dog / Chien

3. Breed

crossbred chihuahua/ Terrier- unspecified

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

7.250

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 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
  • Symptom - Vocalizing
  • Symptom - Discomfort
  • Symptom - Other
  • Specify - Did not want/ was not able to turn his head

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

On 16-Apr-2024, the 11 year old, approximately 7.25 kg, intact male, crossbred Chihuahua/ Terrier, in unknown condition, with concomitant medical condition of fleas, began vocalizing and did not want/ was not able to turn his head, which the animal owner attributed to cervical discomfort (discomfort). The dog was not evaluated, and no treatment was performed. The clinical signs continued. On 17-Apr-2024, the dog was found deceased.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here