Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-4520

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2022_028281

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.

17-JUN-22

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

15-JUN-21

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. 11556-155

Product Name: Seresto Collar Unknown

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

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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 17 Jun 2022, an animal owner contacted Elanco via email regarding a potential adverse event with using Seresto collar unknown in a dog and reported the following: On approximately 01 Jun 2017, a dog was administered the first Seresto collar unknown by the animal owner for flea/tick control. The dog continued to use Seresto through 2022. On approximately 01 Jun 2021, the dog was administered a new Seresto collar. On approximately 01 Mar 2022, the dog was administered a new Seresto collar.

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

Pomeranian

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

5.4

kg

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

• Skin
  • Symptom - Irritated skin
  • Symptom - Lesion
  • Symptom - Itchy skin
  • Symptom - Inflammation of the skin

• Gastrointestinal System
  • Symptom - Loss of appetite

• General
  • Symptom - Death
  • Symptom - Other
  • Specify - Internal lesions

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

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 approximately 15 Jun 2021, the 11-year-old, 5.4 kg, female neutered Pomeranian dog, the dog developed general skin irritation, lesions along the back and legs and itching. A biopsy showed an inflammatory response. The dog was treated with injection of monoclonal antibody against interleukin-31, prednisone, and an antibiotic. On an unknown date, the signs resolved. On an unknown date after the 01Mar2022 application, the lesions returned and the then 12 year old dog had a decreased appetite. The dog also developed internal lesions. The dog died while under anesthesia on 17 Mar 2022.

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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