BEUDAMED
    FDA Adverse Event Other Summary report: N

    TARGIS MDS

    MDR report key: 639311 · Received October 3, 2005

    Report

    Report Number
    2133936-2005-00007
    Event Type
    Other
    Date Received
    October 3, 2005
    Date of Event
    July 12, 2005
    Report Date
    September 21, 2005
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WENT INTO RETENTION POST TREATMENT. PT HAD A RECTAL FISTULA REQUIRING A COLOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS MDS HYPERTHERMIA MICROWAVE/RF SYSTEM MEQ UROLOGIX, INC. 410063-002 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other