BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTECH HUSH-SLUSH DRAPE

    MDR report key: 668118 · Received December 30, 2005

    Report

    Report Number
    668118
    Event Type
    Malfunction
    Date Received
    December 30, 2005
    Date of Event
    July 12, 2005
    Report Date
    December 30, 2005
    Manufacturer
    MICROTECH MEDICAL SYSTEMS, INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON SURGICAL ROOM CLEAN UP HUSH SLUSH DRAPE WAS REMOVED FROM MACHINE AND FLUID NOTED IN THE BOTTOM OF THE WARMER SIDE. PHYSICIANS WERE NOTIFIED OF BREAK IN STERILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTECH HUSH-SLUSH DRAPE DRAPE, FLUID WARMER KKX MICROTECH MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR