BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHROMOPHARE C571

    MDR report key: 468289 · Received June 20, 2003

    Report

    Report Number
    1220685-2003-00003
    Event Type
    Other
    Date Received
    June 20, 2003
    Date of Event
    April 22, 2003
    Report Date
    June 10, 2003
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    A PT WAS POSITIONED ON A SURGICAL TABLE UNDER THE CHROMOPHARE C571 SURGICAL LIGHT WHEN THE LIGHT HANDLE AND LIGHT COVER FELL INTO THE PT'S OPEN INCISION. THE LIGHT WAS BEING REPOSITIONED BY THE LIGHT HANDLE WHEN THE INCIDENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHROMOPHARE C571 SURGICAL LIGHT FSY BERCHTOLD CORP. C571ODCFWO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other