Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2245

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2024_012555

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.

27-MAR-24

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

18-NOV-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)

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

Product Name: Seresto Large Dog Collar

• 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 27 Mar 2024, Elanco was contacted by an animal owner with an inquiry who inadvertently reported the following adverse event when using a Seresto Large Dog (Flumethrin-Imidacloprid) collar. On approximately 15 Nov 2023, a dog had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner for flea control.

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

Old English Sheep Dog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia

• Renal System
  • Symptom - Inappropriate urination

• General
  • Symptom - Abnormal behaviour

• Gastrointestinal System
  • Symptom - Oral hemorrhage

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 approximately 18 Nov 2023, the 3-year-old, intact, male, Sheepdog - Old English dog, of unknown weight, in unknown condition, became lethargic, anorexic, and began displaying behavioral disorders in the form of not wanting to go outside and inappropriate elimination in his cage. The animal owner removed the collar and washed the dog's neck. It is not known whether anything other than water was used. On approximately 21 Nov 2024, the dog was found dead in his cage and had experienced oral hemorrhage.

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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