BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDT CATHETER

    MDR report key: 424473 · Received October 23, 2002

    Report

    Report Number
    MW1026528
    Event Type
    Injury
    Date Received
    October 23, 2002
    Manufacturer
    FIBERS DIRECT
    Product Code
    DQE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BARIUM SWALLOW TO R/O PERF. (WAS R/O'D). AT END OF CASE, PDT DIFFUSER FIBER WAS WITHDRAWN AND DISCOVERED THAT THE END OF DIFFUSER FIBER WAS CHARRED EXPOSING END OF FIBER. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDT CATHETER FIBER DCYL 250 DQE FIBERS DIRECT * 110701

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention