BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCLOSE

    MDR report key: 2022431 · Received March 9, 2011

    Report

    Report Number
    2022431
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    November 16, 2010
    Report Date
    March 9, 2011
    Manufacturer
    ANULEX TECHNOLOGIES
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    SURGEON NOTE THAT THE DEVICE FIRED CORRECTLY THE FIRST TIME BUT IT MISFIRED ON THE SECOND USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCLOSE TISSUE REPAIR SYSTEM GAT ANULEX TECHNOLOGIES * 102656

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR