BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROSTATRON

    MDR report key: 205086 · Received December 29, 1998

    Report

    Report Number
    MW1015373
    Event Type
    Other
    Date Received
    December 29, 1998
    Date of Event
    December 1, 1996
    Report Date
    December 29, 1998
    Manufacturer
    EDAP TECHNOMED, INC.
    Product Code
    MEQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HAD PROSTATRON MICROWAVE THERAPY PERFORMED WITH DR. THIS PROSTATRON DEVICE IS SUPPOSED TO SHRINK THE SIZE OF THE PROSTATE AND DECREASE URINARY RETENTION. IT INCREASED RPTR'S URINARY RETENTION AMOUNT, AND MADE HIS PROSTATE LOOK LIKE IT "HAD CANCER". NO DRUGS WILL EVEN HELP NOW. "SO HAPPEN" OCTOBER 1998 - SEVERE URINARY RETENTION AND ENLARGED PROSTATE, THREE BOARD CERTIFIED UROLOGISTS SAY THIS WAS THE WRONG "PROCEDURE" FOR RPTR. THE DEVICE MADE HIS BENIGN PROSTATIC HYPERTROPHY WORSE. THIS DEVICE SHOULD BE RECALLED BY THE FDA IMMEDIATELY, "IT IS USELESS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTATRON MICROWAVE THERAPY FOR SHRINKING PROSTATE MEQ EDAP TECHNOMED, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other