BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OR SOLUTIONS

    MDR report key: 1932685 · Received December 14, 2010

    Report

    Report Number
    MW5018615
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    O.R. SOLUTIONS, INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HOLE IN IRRIGATION DRAPE WARMER DISCOVERED AFTER THE COMPLETION OF THE SURGERY. POSSIBLE UNSTERILE IRRIGATION THROUGHOUT PROCEDURE, SURGEON AND INFECTION CONTROL NOTIFIED AND AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OR SOLUTIONS WARMER DRAPE KKX O.R. SOLUTIONS, INC. ORS 300

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR