Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-5732

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2023_035697

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.

11-JUL-23

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

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. Unknown

Product Name: Seresto Collar unspecified

• 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 11 Jul 2023, while discussing an adverse reaction with a different product, a pet owner mentioned an adverse event after their coworker used a Seresto Collar unspecified on their dog and reported the following: On an unknown date, a dog was administered a Seresto Collar unspecified (Imidacloprid, Flumethrin) around it's neck by the animal owner for flea and tick prevention. It is unknown if the product was used per label. It is unknown if any 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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

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

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Diarrhea
  • Symptom - Vomiting
  • Symptom - Loss of appetite

• General
  • Symptom - Malaise

• Nervous and Muscular Systems
  • Symptom - Shaking

• Renal System
  • Symptom - Urinary incontinence

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 an unknown date after administration of the collar, the dog of unknown signalment, in unknown condition, with unknown medical conditions, got sick (malaise), exhibited vomiting, diarrhea, and would not eat (loss of appetite), was peeing everywhere (urinary incontinence), and was shaking. It is unknown if the dog was examined by a veterinarian or if any treatments were performed. On an unknown date, the dog died. It is unknown if necropsy was performed.

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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