BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIGHT GUARD

    MDR report key: 2802533 · Received October 19, 2012

    Report

    Report Number
    1825660-2012-00005
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 18, 2012
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    PMA / PMN Number
    112879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER MAILED HER DAMAGED NIGHT GUARD ALONG WITH A NOTE THAT STATED THAT THE END PIECE BROKE OFF AFTER TWO NIGHTS, AND REQUESTED A REPLACEMENT WHICH WAS SENT TO HER. UPON EXAMINATION OF THE DEVICE BY THE MANUFACTURER, WE NOTICED THAT THE CONSUMER SOMEHOW MANAGED TO BITE THE NIGHT GUARD IN A WAY THAT CAUSED THE BITE PAD TO COME OFF. ALTHOUGH THERE WAS NO HARM TO THE CONSUMER, THIS IS A DEVICE MALFUNCTION AS THE BITE PAD IS NOT DESIGNED TO COME OFF. THE BITE PAD GEOMETRY DOES NOT POSE A CHOKING HAZARD. HOWEVER, THE LOOP THAT ATTACHED THE BITE PAD WAS FRACTURED AND REMAINED LOOSELY ATTACHED TO THE DEVICE. IF THE LOOP HAD DETACHED IT COULD POSSIBLY LEAD TO A SERIOUS INJURY IF ASPIRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIGHT GUARD OBR RANIR LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other