BEUDAMED
    FDA Adverse Event Other Summary report: N

    WARMER DRAPE

    MDR report key: 3866690 · Received June 5, 2014

    Report

    Report Number
    MW5036490
    Event Type
    Other
    Date Received
    June 5, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MICROTEK MEDICAL INC.
    Product Code
    KKX
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WARMER LINER USED IN SURGERY TO WARM IRRIGATION FLUID. AT THE END OF THE PROCEDURE, SURGERY WAS COMPLETED AND THE ROOM WAS BEING BROKEN DOWN, THEN A HOLE IN THE DRAPE WAS FOUND. IT IS UNDETERMINED IF THE HOLE WAS CAUSED BECAUSE OF A DEFECT IN THE DRAPE OR IF THE EQUIPMENT BECAME TOO HOT. WE HAVE REMOVED THAT PIECE OF EQUIPMENT AND SENT IT TO THE CLINICAL ENGINEERING DEPARTMENT FOR FURTHER EVALUATION. IT IS UNKNOWN IF IT CAUSED ANY PATIENT INJURY. DIAGNOSIS OR REASON FOR USE: SURGERY - IRRIGATION FLUID IN THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329428 WARMER DRAPE WARMER DRAPE KKX MICROTEK MEDICAL INC. D140221

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA