BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REST ASSURED, GEN II ORIGINAL

    MDR report key: 4241360 · Received November 10, 2014

    Report

    Report Number
    1825660-2014-00946
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 13, 2014
    Report Date
    November 13, 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

    HE HAS BEEN BUYING THE PRODUCT FOR QUITE SOME TIME USUALLY LAST FOR ABOUT 3-4 MONTHS. ON 2 OCCASIONS AFTER 2 WEEKS THE HARD AND SOFT MATERIAL BEGAN TO SEPARATE. THE GUARDS HAD THE TRIMMING RIDGES INDICATING THEY ARE THE GEN II ORIGINAL GUARDS.

    Description of Event or Problem · 1

    HE HAS BEEN BUYING THE PRODUCT FOR QUITE SOME TIME USUALLY LAST FOR ABOUT 3-4 MONTHS. ON 2 OCCASIONS AFTER 2 WEEKS THE HARD AND SOFT MATERIAL BEGAN TO SEPARATE. THE GUARDS HAD THE TRIMMING RIDGES INDICATING THEY ARE THE GEN II ORIGINAL GUARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723280 REST ASSURED, GEN II ORIGINAL MOUTH GUARD OBR RANIR, LLC REST ASSURED, GEN II ORIGINAL

    Patients

    Seq Age Sex Outcome Treatment
    1