BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-X MITRAL PROSTHETIC HEART VALVE

    MDR report key: 5001652 · Received August 11, 2015

    Report

    Report Number
    1649833-2015-00016
    Event Type
    Death
    Date Received
    August 11, 2015
    Date of Event
    January 18, 2013
    Report Date
    August 10, 2015
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    UDI-DI
    00851788001280
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525343 ON-X MITRAL PROSTHETIC HEART VALVE MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC. ONXM-27/29 00851788001280

    Patients

    Seq Age Sex Outcome Treatment
    0 Death
    1 66 YR Death