BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDT CATHETER

    MDR report key: 426973 · Received November 6, 2002

    Report

    Report Number
    MW1026679
    Event Type
    Malfunction
    Date Received
    November 6, 2002
    Date of Event
    October 21, 2002
    Report Date
    October 25, 2002
    Manufacturer
    FIBERS DIRECT
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PDT TREATMENT A 5 MM FIBER BURNED THROUGH. TREATMENT STOPPED, FIBER REPLACED AND PROCEDURE THEN COMPLETED. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDT CATHETER FIBER DCYL 250 GEX FIBERS DIRECT * 041602

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other