BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTATRON

    MDR report key: 339620 · Received May 2, 2001

    Report

    Report Number
    MW1022268
    Event Type
    Injury
    Date Received
    May 2, 2001
    Date of Event
    March 17, 2000
    Manufacturer
    EDAP TECHNOMED, INC.
    Product Code
    MEQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: TRANSURETHRAL MICROWAVE THERAPY; ANESTHESIA: GENERAL; PREOPERATIVE DIAGNOSIS: BENIGN PROSTATIC HYPERTROPHY; POSTOPERATIVE DIAGNOSIS: BENIGN PROSTATIC HYPERTROPHY. DESCRIPTION: THE PT WAS TAKEN TO THE OPERATING SUITE. HAD BEEN GIVEN A GENERAL ANESTHESIA BY DR. A CATHETER WAS THEN PLACED AND THE BLADDER DRAINED. 50CC OF FLUID WERE THEN PUT INTO THE BLADDER TO ALLOW VISUALIZATION WITH THE ULTRASOUND. THE PROSTAPROBE CATHETER 2.5 WAS THEN INSERTED INTO THE BLADDER. THE BALLOON WAS INFLATED AND PROPER POSITION WAS IDENTIFIED WITH THE USE OF ULTRASOUND. AT THIS TIME THE TRANSURETHRAL MICROWAVE THERAPY PROCEDURE WAS CARRIED OUT FOR APPROXIMATELY ONE HR. THE POSITION OF THE CATHETER, URETERAL AND RECTAL TEMPERATURES WERE MONITORED THROUGHOUT THE PROCEDURE. THE PT RECEIVED 206 KILOJOULES OF ENERGY AND TOLERATED THE PROCEDURE WELL AND LEFT THE OPERATING ROOM SUITE IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20784 PROSTATRON MICROWAVE THERMOTHERAPY MEQ EDAP TECHNOMED, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Congenital Anomaly| O| R| S