Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2022-2918

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2021-US0028935

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.

06-APR-21

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

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. 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 approximately 07-Jun-2019, a canine had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner.

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

Golden Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

24.6

kg

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

Unknown / Inconnu

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - unspecified muscular issues with head
  • Symptom - Other
  • Specify - unspecified neurological issues with head

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Head tilt
  • Symptom - Other
  • Specify - Meningoencephalitis
  • Symptom - Other
  • Specify - Right sided vestibular dysfunction

• General
  • Symptom - Loss of balance

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Trouble posturing to defecate
  • Symptom - Difficulty walking
  • Specify - Unable to do stairs

• Gastrointestinal System
  • Symptom - Loss of appetite

• Respiratory System
  • Symptom - Panting

• Nervous and Muscular Systems
  • Symptom - Difficulty walking
  • Specify - Not walking

• Gastrointestinal System
  • Symptom - Difficulty swallowing
  • Specify - Not able to swallow

• Eye
  • Symptom - Nystagmus

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Decreased menace response
  • Symptom - Other
  • Specify - Decreased palpebral reflex

• Eye
  • Symptom - Other
  • Specify - Small but somewhat responsive pupils

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Decreased gag movement
  • Symptom - Other
  • Specify - Decreased tongue movement

12. How long did the symptoms last?

Persisted until death

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 an unknown date, shortly after collar application, the canine, of unknown signalment and condition, with no known concomitant medical conditions, exhibited muscular and neurological issues with his head. On 3 July 2019 and on 15 July 2019, the animal was examined by a veterinarian. It was unknown if any treatment was performed. On 15-July-2019, the dog died. No known 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