BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLEGIANCE WOUND EVACUATION

    MDR report key: 400881 · Received June 20, 2002

    Report

    Report Number
    1043582-2002-00003
    Event Type
    Other
    Date Received
    June 20, 2002
    Date of Event
    September 15, 2001
    Report Date
    June 20, 2002
    Manufacturer
    MICROTEK MEDICAL, INC.
    Product Code
    GCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT KNEE SURGERY AT WHICH TIME A WOUND EVACUATION DEVICE WAS PLACED AND UTILIZED ON THE PT. THE WOUND EVAC WAS REMOVED WITH NO APPARENT DIFFICULTY. THE PT RETURNED TO THE PHYSICIANS OFFICE 13 DAYS LATER FOR FOLLOW-UP. X-RAYS REVEALED PART OF THE TUBING WAS LEFT IN THE PT KNEE. THE PT WAS RETURNED TO SURGERY FOR REMOVAL OF THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGIANCE WOUND EVACUATION WOUND EVACUATION DEVICE GCX MICROTEK MEDICAL, INC. SU130-402D MM01130

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention