BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REST ASSURED, GEN II ORIG

    MDR report key: 4097160 · Received September 17, 2014

    Report

    Report Number
    1825660-2014-00914
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 18, 2014
    Report Date
    September 17, 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 EVENT HAPPENED IN (B)(6). NO INJURY WAS REPORTED, NO MEDICAL ATTENTION WAS REPORTED TO HAVE BEEN SOUGHT, DEVICE WAS NOT USED BY CONSUMER. 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

    BOUGHT THE GRIND GUARD. I USED IT LESS THAN THREE WEEKS AND IT HAS FALLEN APART. I HAVE PURCHASED THESE BEFORE AND I AM DISAPPOINTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574658 REST ASSURED, GEN II ORIG NITE GUARD OTC OBR RANIR, LLC REST ASSURED GEN II ORG

    Patients

    Seq Age Sex Outcome Treatment
    1