BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROSTATRON

    MDR report key: 651449 · Received December 7, 2005

    Report

    Report Number
    2133936-2005-00010
    Event Type
    Other
    Date Received
    December 7, 2005
    Report Date
    December 6, 2005
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER CALLED TO REPORT A PATIENT THAT DEVELOPED A RECTAL FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTATRON MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC. 400023-007 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other