BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REST ASSURED, GEN II

    MDR report key: 4111229 · Received September 23, 2014

    Report

    Report Number
    1825660-2014-00920
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 23, 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

    PRODUCT FELL APART AFTER 4 USES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589806 REST ASSURED, GEN II MOUTH GUARD OBR RANIR, LLC REST ASSURED, GEN II

    Patients

    Seq Age Sex Outcome Treatment
    1