BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLEGIANCE WOUND EVACUATION

    MDR report key: 383264 · Received February 25, 2002

    Report

    Report Number
    8043817-2002-00001
    Event Type
    Other
    Date Received
    February 25, 2002
    Date of Event
    February 2, 2002
    Report Date
    February 19, 2002
    Manufacturer
    MICROTEK MEDICAL, INC.
    Product Code
    GCY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED TO USER FACILITY FOR ABDOMINAL HYSTERECTOMY. TWO ALLEGIANCE 1/8" WOUND EVACUATION DRAINS WERE PLACED IN THE OPERATIVE SITE BY THE PHYSICIAN. UPON REMOVAL OF THE DRAINS, ONE WOULD NOT REMOVE WITH NORMAL FORCE. THE STAFF NURSE PULLED ON THE DRAIN AND THE DRAIN SNAPPED LEAVING A LARGE PIECE INSIDE THE PATIENT. THE PIECE OF DRAIN WAS SURGICALLY REMOVED BY THE PHYSICIAN. THE DRAIN AND THE REMOVED PIECE WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGIANCE WOUND EVACUATION WOUND EVACUATION DEVICE GCY MICROTEK MEDICAL, INC. * NI

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization