BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOMNOGUARD MANDIBULAR ADVANCEMENT DEVICE

    MDR report key: 10104960 · Received May 29, 2020

    Report

    Report Number
    MW5094760
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    May 23, 2020
    Manufacturer
    TOMED, GMBH.
    Product Code
    LRK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON THE MORNING OF (B)(6) 2020, I WAS SLEEPING BUT BEGINNING TO WAKE UP WHEN I FELT SOMETHING ON MY TONGUE. I HAD MY ORAL APPLIANCE IN PLACE FOR THE TREATMENT OF MY SLEEP APNEA. IT WAS DIFFICULT TO MANEUVER MY TONGUE TO GET THE OBJECT TO A POINT WHERE I WOULD NOT ASPIRATE IT OR SWALLOW IT. AFTER GETTING IT UNDER MY TONGUE, I REMOVED THE APPLIANCE AND DISCOVERED THE SCREW IN THE APPLIANCE HAD BROKEN. THE NUT REMAINED ATTACHED TO THE OTHER PORTION OF THE SCREW STILL IN THE APPLIANCE. HAD I NOT BEEN IN THE STATE BETWEEN SLEEP AND AWAKENING, I WOULD HAVE ASPIRATED THE SCREW AND BEEN SERIOUSLY INJURED IF NOT KILLED. THIS INCIDENT WAS A NEAR MISS TO SAY THE LEAST. FDA SAFETY REPORT ID #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567307 SOMNOGUARD MANDIBULAR ADVANCEMENT DEVICE DEVICE, ANTI-SNORING LRK TOMED, GMBH. SOMNOGUARD AP PRO

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other