BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM

    MDR report key: 2003818 · Received February 7, 2011

    Report

    Report Number
    2003818
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 7, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    THE DEVICE FAILED TO WORK PROPERLY AND SURGEON WAS UNABLE TO USE TO CLOSE. IT FAILED TO SUTURE ARTERY AND WAS REMOVED FROM THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT LABORATORIES 12673 *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR