BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REST ASSURED GEN II ORIG.

    MDR report key: 4086227 · Received September 12, 2014

    Report

    Report Number
    1825660-2014-00907
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 27, 2014
    Manufacturer
    RANIR, LLC
    Product Code
    OBR
    PMA / PMN Number
    K091792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT HAS NOT BEEN CONFIRMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AND NO LOT NUMBER INFORMATION WAS GIVEN SO AN EVALUATION CANNOT BE PERFORMED AS TO THE ROOT CAUSE OR ACTUAL NATURE OF THE PROBLEM. NO INJURY WAS REPORTED, NO MEDICAL ATTENTION WAS REPORTED TO HAVE BEEN SOUGHT. THIS IS BEING REPORTED AS A POSSIBLE PRODUCT MALFUNCTION THAT COULD POTENTIALLY RESULT IN SERIOUS INJURY. MEDICAL INTERVENTION MAY BE REQUIRED IF THE DEVICE IS SWALLOWED AND GOES BEYOND THE PHARYNGEAL ARCH.

    Description of Event or Problem · 1

    THE CONSUMER STATED: THE INSIDE IS OK, IT'S SOFT. BUT THE OUTSIDE MUST BE HARD MATERIAL, SO WHEN GRINDING THE PIECE WOULD SLIDE OFF, PREVENTING THE SPLIT OF DENTAL PROTECTORS. THE PIECES CAME APART AT THE SECOND NIGHT OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565575 REST ASSURED GEN II ORIG. NITE GUARD OBR RANIR, LLC GEN II ORIG

    Patients

    Seq Age Sex Outcome Treatment
    1