BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE

    MDR report key: 7137726 · Received December 21, 2017

    Report

    Report Number
    7137726
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 6, 2017
    Report Date
    December 13, 2017
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE WAS A MISFIRE OF FOUR PROGLIDE DEVICES. ANOTHER DEVICE WAS OPENED AND USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918200 PERCLOSE PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-03

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR