BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMEDYNE

    MDR report key: 697998 · Received March 29, 2005

    Report

    Report Number
    MW1038377
    Event Type
    Malfunction
    Date Received
    March 29, 2005
    Date of Event
    December 12, 2005
    Report Date
    March 23, 2006
    Manufacturer
    FLEX MAX
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    1230 LASER PROBE BROKE OUTSIDE OF PT WHILE TIP WAS INSERTED IN PT. TIP WAS REMOVED, SAFELY CLEAN BREAK MATERIAL. PT ASLEEP BY ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMEDYNE LASER PROBE GEX FLEX MAX REF B365 50527

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR