BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REST ASSURED, GEN II ORIGINAL

    MDR report key: 4232912 · Received November 6, 2014

    Report

    Report Number
    1825660-2014-00941
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 7, 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

    Description of Event or Problem · 1

    CONSUMER STATED THAT THE MOUTH GUARD FELL APART AFTER ONLY ONE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713095 REST ASSURED, GEN II ORIGINAL MOUTH GUARD OBR RANIR, LLC REST ASSURED, GEN II ORIGINAL

    Patients

    Seq Age Sex Outcome Treatment
    1