BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLATE DRAPE

    MDR report key: 486225 · Received October 1, 2003

    Report

    Report Number
    486225
    Event Type
    Other
    Date Received
    October 1, 2003
    Date of Event
    December 1, 2001
    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

    SURGICAL DRAPE LEAKAGE/STERILE FIELD CONTAMINATION. WHILE CLEANING THE ROOM FOLLOWING A RIGHT CADRAVERIC KIDNEY TRANSPLANT SURGERY, THE PLASTIC DRAPE COVERING THE WARMER WAS NOTED TO BE LEAKING. THE ROOM WAS CLEANED IMMEDIATELY FOLLOWING THE SURGERY. IT IS NOT KNOWN IF THE DRAPE APPEARED TO BE TORN OR BURNED. THE PHYSICIAN WAS NOTIFIED OF THE BREAK IN THE STERILE FIELD. THE WRAPPER WOULD BE SAVED FOR THE REFERENCE OF TRENDS SHOULD THIS HAPPEN AGAIN. THE WRAPPER WAS SAVED IN THE ASSISTANT OPERATING ROOM DIRECTOR'S OFFICE. THE PT DID RECEIVE TMP/SULFA POST-OPERATIVELY. THE STANDARD POST-OPERATIVE FOLLOW-UP REVEALED AN UNCOMPLICATED COURSE.

    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 60 YR