BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZQUIET

    MDR report key: 22769963 · Received August 11, 2025

    Report

    Report Number
    3008797926-2025-31001
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    March 12, 2025
    Report Date
    May 19, 2025
    Manufacturer
    SLEEPING WELL, LLC
    Product Code
    LRK
    UDI-DI
    00858522003333
    PMA / PMN Number
    K180124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    CUSTOMER ALLEGES DEVICE USED CAUSED DEGENERATIVE WEAR OF HIS RIGHT TEMPEROMANDIBULAR JOINT AND BITE ALIGNMENT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1914826 ZQUIET ZQUIET ANTI-SNORING MOUTHPIECE LRK SLEEPING WELL, LLC AA1094 00858522003333

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention