BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLEGIANCE WOUND EVACUATION

    MDR report key: 389188 · Received April 18, 2002

    Report

    Report Number
    1043582-2002-00002
    Event Type
    Other
    Date Received
    April 18, 2002
    Date of Event
    March 11, 2002
    Report Date
    April 18, 2002
    Manufacturer
    MICROTEK MEDICAL, INC.
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD WOUND EVACUATION DEVICE PLACED IN BACK WOUND IN 2002. TWO DAYS LATER, PT WAS TO HAVE DEVICE REMOVED. A PORTION OF THE TUBING BROKE OFF AND REMAINED IN WOUND. HOSP STATED THAT TUBING COULD HAVE CAUGHT ON STAPLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention