Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-6708

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2023_055217

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.

29-SEP-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. 11556-155

Product Name: Seresto Small 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 29 Sep 2023, an animal owner posted online regarding an adverse event involving Seresto Small Dog and reported the following: On an unknown date, a dog was applied a Seresto Small Dog (Imidacloprid, Flumethrin) topically by an animal owner for flea/tick control. It was unknown if the product was used correctly. It was 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Miniature Pinscher

4. Number of animals affected

1

5. Sex

Male

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

• Nervous and Muscular Systems
  • Symptom - Ataxia
  • Symptom - Paralysis

• General
  • Symptom - Weakness

• Nervous and Muscular Systems
  • Symptom - Abnormal gait
  • Symptom - Abnormal posture
  • Symptom - Difficulty walking

12. How long did the symptoms last?

Persisted until death

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 application of the Seresto collar, the male Miniature Pinscher, of unknown age and weight, in unknown condition, with no known concomitant medical conditions, slowly lost the use of his legs (paralysis). First the dog would just be a little wobbly (ataxia) on occasion, then his back legs would work on and off then not at all (paralysis). The dog would drag himself around with his front legs until they too stopped working (paralysis). Then at times he couldnat support his head (weakness). On unknown date, the animal died, still wearing the collar.

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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