BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOP DRAPE

    MDR report key: 761049 · Received September 1, 2006

    Report

    Report Number
    761049
    Event Type
    Malfunction
    Date Received
    September 1, 2006
    Date of Event
    August 8, 2006
    Report Date
    September 1, 2006
    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

    UPON ROOM CLEANUP IN OR SUITE AFTER COMPLETION OF THE SURGICAL PROCEDURE, SCRUB NURSE NOTED FLUID IN THE BASIN YET OUTSIDE OF THE WARMING DRAPE. UPON FURTHER INSPECTION, "SMALL HOLE WAS FOUND TO BE IN THE AREA OF A BLUE MARKER AREA" THAT MAKES CONTACT WITH THE INSIDE OF THE BASIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOP DRAPE DRAPE, SURGICAL WARMER KKX O.R. SOLUTIONS, INC. ORS-2075R 0506131

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR