BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDINAL/ALLEGIANCE WOUND EVAC.

    MDR report key: 510562 · Received February 9, 2004

    Report

    Report Number
    1043582-2004-00001
    Event Type
    Other
    Date Received
    February 9, 2004
    Date of Event
    October 29, 2003
    Report Date
    February 4, 2004
    Manufacturer
    MICROTEK MEDICAL, INC.
    Product Code
    GCY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A LEFT TOTAL KNEE ARTHROSPLASTY IN 2003 WITH A LATERAL RETINOCULAR RELEASE AND MEDIAL HEMOVAC DRAIN PLACEMENT. TWO DAYS LATER AN ATTEMPT WAS MADE TO REMOVE THE DRAIN. HOWEVER, IT WAS DIFFICULT TO REMOVE AND THE TIP REMAINED IN THE KNEE. THE NEXT DAY THE PT WAS RETURNED TO THE O.R. WHERE THE DRAIN TIP WAS REMOVED UNDER GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDINAL/ALLEGIANCE WOUND EVAC. WOUND EVACUATION DEVICE GCY MICROTEK MEDICAL, INC. SU-130-4020 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *