BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANAULUX

    MDR report key: 978276 · Received November 9, 2007

    Report

    Report Number
    3004147784-2007-00028
    Event Type
    Malfunction
    Date Received
    November 9, 2007
    Date of Event
    September 21, 2007
    Report Date
    October 12, 2007
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON A HLX 2000 SURGICAL LIGHT CONFIGURATION, THE STERILIZABLE HANDLE SUPPORT OF THE CAMERA HOLDER DROPPED ONTO THE PT'S FOREHEAD DURING A SURGICAL PROCEDURE. THE CUSTOMER REPORTED THAT THE PT DELVEOPED A BUMP ON THE FOREHEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANAULUX FSY FSY MAQUET S.A. HLX 2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *