BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISC - DRAPE

    MDR report key: 335365 · Received May 29, 2001

    Report

    Report Number
    MW1022018
    Event Type
    Malfunction
    Date Received
    May 29, 2001
    Date of Event
    April 19, 2001
    Report Date
    May 23, 2001
    Manufacturer
    O.R. SOLUTIONS, INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DRAPE USED IN SLUSH MACHINE DURING PROCEDURE. WATER WAS FOUND IN THE BOTTOM OF THE SLUSH MACHINE AT THE END OF THE PROCEDURE. DRAPE WAS EXAMINED BUT NO TEARS WERE VISIBLE, BUT LEAKED WHEN TESTED WITH WATER. THERE WAS NO APPARENT INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24801 DISC - DRAPE SOLUTION DRAPE KKX O.R. SOLUTIONS, INC. * 31300

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR