Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-5102

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2023_029153

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.

12-JUN-23

5. Location of incident.

Country: UNITED STATES

Prov / State: ARKANSAS

6. Date incident was first observed.

08-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 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 12 Jun 2023, an animal owner contacted Elanco regarding a potential adverse event and lack of efficacy after using a Seresto Small Dog Collar on a dog. On 16 Jan 2023, the dog was administered 1 Seresto Small Dog Collar by the owner for flea/tick control. It is unknown if the product was applied per labelled instructions. It is unknown if concomitant products 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

Pug

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

13.5

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

>2 mos <=6 mos / > 2 mois < = 6 mois

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Hemorrhage
  • Symptom - Parasitism

• Skin
  • Symptom - Hair loss
  • Symptom - Pruritus

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

On 08 Apr 2023, an approximately 13.5 year old, female, Pug breed dog, in unknown condition with unknown concomitant medical conditions, exhibited a flea infestation, scratching until bleeding, and hair loss. It is unknown if the dog was examined by a veterinarian. The product was discontinued, and the dog switched to unspecified chewable flea/tick control tablets. Signs resolved with no further treatment. On 11 Jun 2023, the dog died. The owner attributed the dog's death to old age and not the Seresto Collar.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here