BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCORE SYSTEM

    MDR report key: 22527918 · Received July 17, 2025

    Report

    Report Number
    3008792120-2025-00002
    Event Type
    Injury
    Date Received
    July 17, 2025
    Date of Event
    July 1, 2025
    Report Date
    July 16, 2025
    Manufacturer
    SIESTA MEDICAL, INC.
    Product Code
    ORY
    PMA / PMN Number
    K213159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED WITH THE ENCORE SYSTEM ON (B)(6) 2024. ON (B)(6) 2025, THE PHYSICIAN REPORTED THE PATIENT HAD NECK SWELLING AND DRAINAGE FOLLOWING SURGERY AND WAS TREATED WITH ANTIBIOTICS FOR SEVERAL MONTHS WITHOUT RESOLVING THE SYMPTOMS. THE PHYSICIAN DECIDED TO EXPLANT THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647094 ENCORE SYSTEM INTRAORAL DEVICE FOR SNORING OR SLEEP APNEA ORY SIESTA MEDICAL, INC. FG0002 1148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention