Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-0361

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2021_036369

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 150 Research Lane, Suite 120

City: Guelph

Prov / State: ON

Country: Canada

Postal Code: N1G 4T2

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

08-NOV-21

5. Location of incident.

Country: UNITED STATES

Prov / State: KANSAS

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 08 Nov 2021, Elanco was contacted by a clinic staff member regarding a potential adverse event involving a Seresto Small Dog Collar and reported the following: On approximately 01 Aug 2021, a dog, in unknown condition, with a preexisting heart disease, had one Small Dog Seresto Collar placed on by the animal owner for flea/tick control.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

5.2

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

• General
  • Symptom - Death

• Cardiovascular System
  • Symptom - Other
  • Specify - Heart failure

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, the 8-year-old, neutered female, 5.2 kg, Chihuahua dog, died due to heart failure. The clinic staff member did not indicate suspicion that Seresto was involved in the death of the dog.

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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