BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILENT NITE

    MDR report key: 6879334 · Received September 19, 2017

    Report

    Report Number
    MW5072229
    Event Type
    Malfunction
    Date Received
    September 19, 2017
    Date of Event
    September 14, 2017
    Report Date
    September 18, 2017
    Manufacturer
    GLIDEWELL DENTAL LABS
    Product Code
    LRK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE GLIDEWELL LABORATORIES SILENT NITE SNOREGUARD DID NOT WORK WELL AND HAD QUALITY PROBLEMS FOR ME. AFTER A FEW DAYS OF USE, THE PLASTIC BANDS THAT ARE SUPPOSED TO PROJECT THE JAW FORWARD AND REDUCE SNORING SEEMED TO STRETCH AND BECOME INEFFECTIVE. MY DENTIST RETURNED THE SNOREGUARD TO THE COMPANY FOR A REPLACEMENT, AND THEY REPLACED ONLY THE LOWER JAW PORTION OF THE DEVICE. THE REPLACEMENT SEEMED TO BE OF A DIFFERENT MATERIAL THAN THE UPPER PORTION, WHICH STAINED QUICKLY. THE LOWER PART OF THE DEVICE DID NOT STAIN, BUT THE PLASTIC BANDS HAD A SIMILAR PROBLEM, AND WITHIN A MATTER OF DAYS THEY HAD STRETCHED AGAIN, REDUCING EFFECTIVENESS. WITHIN ABOUT A MONTH, THE CONNECTOR THAT HOLDS THE PLASTIC BANDS IN PLACE ON THE LOWER RIGHT SNAPPED OFF, RENDERING THE ENTIRE DEVICE USELESS. IT IS RIDICULOUS THAT I NEEDED A PRESCRIPTION FOR A DEVICE LIKE THIS. THE COMPANY NEEDS TO GO BACK TO THE DRAWING BOARD AND RE-EXAMINE THE MATERIALS IT USES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654842 SILENT NITE SNORE GUARD LRK GLIDEWELL DENTAL LABS

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR