BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-X CONFORM-X MITRAL PROSTHETIC HEART VALVE

    MDR report key: 2522721 · Received June 28, 2010

    Report

    Report Number
    1649833-2010-00007
    Event Type
    Malfunction
    Date Received
    June 28, 2010
    Date of Event
    April 20, 2010
    Report Date
    June 25, 2010
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TRYING TO GET THE VALVE BACK SO WE CAN INVESTIGATE.

    Description of Event or Problem · 1

    PER USER FACILITY MEDWATCH REPORT #(B)(4), "ON-X VALVE (CONFORM-X) 25/33 WAS PLACED AND ONE OF THE LEAFLETS WAS NOT FUNCTIONING - REQUIRED REMOVAL AND NEW VALVE REPLACED." PER (B)(4) ON USER FACILITY MEDWATCH FORM, HEART VALVE REPAIR WAS INVOLVED. NO OTHER INFO IS AVAILABLE. ON-X LIFE TECHNOLOGIES, INC IS TRYING TO GET THE VALVE BACK FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-X CONFORM-X MITRAL PROSTHETIC HEART VALVE MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC. ONXMC

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention