BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE DRAPE

    MDR report key: 503048 · Received December 29, 2003

    Report

    Report Number
    503048
    Event Type
    Malfunction
    Date Received
    December 29, 2003
    Date of Event
    October 1, 2003
    Report Date
    November 1, 2003
    Manufacturer
    O.R. SOLUTIONS, INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PLATE DRAPE THAT WAS USED FOR KIDNEY TRANSPLANT WAS FOUND LEAKING WHEN REMOVED FROM THE ICE MACHINE. LEAKING OCCURRED WHERE THE PLASTIC DRAPE ATTACHES TO THE PLATE. FLUID WAS AROUND IN THE COOLING UNIT CAUSING CONTAMINATION TO THE CONTENTS INSIDE THE BASIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATE DRAPE SOLUTION DRAPE - HUSH SLUSH KKX O.R. SOLUTIONS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR