BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLEEP RIGHT

    MDR report key: 1951134 · Received December 30, 2010

    Report

    Report Number
    MW5018862
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 30, 2010
    Manufacturer
    SPLINTEK
    Product Code
    OBR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    I PURCHASED AND USED THE SLEEP RIGHT NIGHT GUARD TO PREVENT BRUXISM. HOWEVER, ONE NIGHT I WOKE UP TO FIND THAT THE TWO PIECE GUARD WAS BROKEN AND TWO PIECES OF PLASTIC WERE IN MY MOUTH, THE PIECES WERE LARGE ENOUGH THAT IF I SWALLOWED THEM IN MY SLEEP I WOULD HAVE CHOKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEP RIGHT NIGHT GUARD OBR SPLINTEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening