BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE DRAPE

    MDR report key: 498251 · Received October 27, 2003

    Report

    Report Number
    498251
    Event Type
    Malfunction
    Date Received
    October 27, 2003
    Date of Event
    June 1, 2003
    Report Date
    August 1, 2003
    Manufacturer
    OR 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

    WHEN THE HUSH SLUSH DRAPE WAS REMOVED, THERE WAS APPROXIMATELY 30 CC OF FLUID IN THE WARMER. NO NOTICEABLE HOLES SEEN IN THE DRAPE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR