BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITE GUARD

    MDR report key: 3994144 · Received July 24, 2014

    Report

    Report Number
    1825660-2014-00884
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 16, 2014
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    PMA / PMN Number
    K112879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER RECEIPT OF THE PRODUCT FOR INVESTIGATION, IT APPEARS THAT THERE IS NO "BUBBLING" OR VOIDS IN THE DEVICE. THIS DEVICE WAS MOLDED CORRECTLY. THE DEVICE SEEMS TO HAVE BEEN EXTENSIVELY CHEWED UP AFTER THE STATED "ONE USE" CAUSING THE SOFTER BITE PAD MATERIAL TO BE SEPARATED FROM THE BASE MATERIAL. THIS DEVICE IS INTENDED FOR MILD TO MODERATE BRUXISM, NOT THE SEVERE BRUXISM OF WHICH IT APPEARS TO HAVE BEEN SUBJECTED. THIS REPORT HAS NOT BEEN CONFIRMED, NO INJURY WAS REPORTED, AND NO MEDICAL ATTENTION WAS SOUGHT. THIS IS BEING REPORTED EVEN THOUGH THE DEVICE WAS USED OUTSIDE THE INTENDED USE INDICATED ON THE LABELING. CHEWED UP PIECES OF THIS DEVICE CAN BE ASPIRATED WHICH COULD CAUSE AN INJURY REQUIRING SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    I ENCLOSE WITH THIS LETTER 2 NIGHT-TIME PROTECTORS. AFTER WEARING EACH ONE FOR SEVEN HOURS, THE AREAS UNDER THE BITE PADS HAD FORMED A BUBBLE OR BLISTER EFFECT. WHEN I CLEANED THEM, THE RAISED AREAS FILLED WITH WATER BECAUSE EACH HAD WORN THROUGH THE OTHER BOTTOM LAYER, ALLOWING A SPACE FOR BACTERIA TO FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433835 NITE GUARD MOUTHGUARD, OVER THE COUNTER OBR RANIR LLC NO BOIL

    Patients

    Seq Age Sex Outcome Treatment
    1