BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER HOLMIUM LASER FIBER

    MDR report key: 882653 · Received July 13, 2007

    Report

    Report Number
    1037955-2007-00034
    Event Type
    Malfunction
    Date Received
    July 13, 2007
    Date of Event
    November 11, 2005
    Report Date
    July 11, 2007
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    PMA / PMN Number
    022544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FIBER RETURNED 12/19/2005. EMAIL ON 12/20/2005 STATED "POSSIBLY THE CONNECTOR FELL OFF OR BECAME DISCONNECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORNIER HOLMIUM LASER FIBER LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. HF0600RSSM C4004-02R

    Patients

    Seq Age Sex Outcome Treatment
    1 YR