BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE-DRAPE

    MDR report key: 487907 · Received October 6, 2003

    Report

    Report Number
    487907
    Event Type
    Malfunction
    Date Received
    October 6, 2003
    Date of Event
    December 1, 2002
    Report Date
    December 1, 2002
    Manufacturer
    O.R. SOLUTIONS, 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

    PT UNDERWENT A RENAL TRANSPLANT. PERFORATION OF SURGICAL FLUID BARRIER DRAPE WAS NOTED AFTER THE CASE HAD ENDED. THE SURGICAL FIELD AND WOUND WERE POTENTIALLY CONTAMINATED. HUSH-SLUSH DRAPE TO COVER AN ELECTRIC ICE MAKER AND FLUID WARMER COMBINATION (ICE TO COOL THE KIDNEY AND WARMTH TO HEAT THE SALINE FOR IRRIGATION). THE DRAPE WAS DISCARDED FOLLOWING THE COMPLETION OF THE OPERATION. THE PT WAS PLACED ON ANTIBIOTIC THERAPY AS A PROPHYLACTIC MEASURE. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION-THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATE-DRAPE SOLUTION DRAPE KKX O.R. SOLUTIONS, INC H3204102D *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other