BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSOMNUS EVO

    MDR report key: 23805932 · Received December 15, 2025

    Report

    Report Number
    MW5180513
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    November 25, 2025
    Report Date
    December 8, 2025
    Manufacturer
    PROSOMNUS SLEEP TECHNOLOGIES
    Product Code
    LRK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A JAGGED FRAGMENT BROKE OFF OF MY PROSOMNUS SLEEP APNEA DEVICE WHILE I WAS SLEEPING AND WAS LOOSE IN MY MOUTH. I WAS ABLE TO WAKEN AND RETRIEVE THE FRAGMENT BEFORE SUCKING IT INTO MY AIRWAY. I HAVE NOT BEEN ABLE TO SLEEP WELL SINCE THE INCIDENT DUE TO DISTRESS AND MENTAL ANGUISH OVER THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743511 PROSOMNUS EVO DEVICE, ANTI-SNORING LRK PROSOMNUS SLEEP TECHNOLOGIES EVO

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Disability| L ATORVASTATIN.| INSULIN VIA TANDEM PUMP.| MEN'S ONCE DAILY MULTI VITAMIN.| METOPROLOL.| PROSOMNUS EVA SLEEP APNEA DEVICE.