BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENOORE SYSTEM

    MDR report key: 23363892 · Received October 22, 2025

    Report

    Report Number
    3008792120-2025-00005
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    August 24, 2025
    Report Date
    October 22, 2025
    Manufacturer
    SIESTA MEDICAL, INC.
    Product Code
    ORY
    PMA / PMN Number
    K213159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORT PUS FORMATION IN THE AREA OF THE PROCEDURE. CULTURES WERE TAKEN, BUT NO RESULTS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2815629 ENOORE SYSTEM INTRAORAL DEVICE FOR SNORING OR SLEEP APNEA ORY SIESTA MEDICAL, INC. FG0002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R