BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTATRON

    MDR report key: 276738 · Received April 7, 2000

    Report

    Report Number
    MW4002751
    Event Type
    Injury
    Date Received
    April 7, 2000
    Date of Event
    January 3, 2000
    Report Date
    April 6, 2000
    Manufacturer
    EDAP TECHNOMED, INC.
    Product Code
    MEQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD A PROSTATRON PROCEDURE AT MEDICAL CTR. HALF-WAY THROUGH THE PROCESS, RPTR'S BLOOD PRESSURE DROPPED FROM 150/94 TO 68/43, AND HEART RATE 82 TO 42, IN A 5 MIN PERIOD. AFTER GETTING THE ATTENDING PERSONNEL'S ATTENTION, THAT SOMETHING WAS WRONG, RPTR WAS TAKEN OFF THE MACHINE, AND A HEART DR WAS CALLED IN. WHEN RPTR WAS STABILIZED, THE MACHINE WAS RE-STARTED. WHEN IT WAS FINISHED, RPTR WAS TAKEN TO THE RECOVERY ROOM FOR 1 1/2 HRS. THIS SIMPLE PROCEDURE THAT "TAKES ABOUT AN HR, REQUIRES NO ANESTHESIA AND HAS NONE OF THE MAJOR RISKS OF SURGERY", (SEE ENCLOSED AD), WAS ANYTHING BUT. RPTR CAME HOME EIGHT HRS AFTER ENTERING THE HOSP WITH "THE MOST EXCRUCIATING PAIN." FOUR DAYS LATER, WHEN RPTR REMOVED THE CATHETER, (DR'S INSTRUCTIONS), THE PAIN WAS UNBEARABLE, WHEN URINATING. RPTR HAD NO CONTROL, AND IF THEY TRIED TO WAIT TO VOID, TERRIFIC PAINS WOULD SHOOT UP LEFT SIDE. ON 3/15/2000, WHILE AT A MEETING, RPTR'S DIMINISHED URINE FLOW COMPLETELY STOPPED, WITH THE RESULT BEING THAT RPTR HAD TO GO TO THE HOSP ER AND HAVE A CATHETER INSERTED. HAVING HAD ENOUGH, RPTR MADE AN APPOINTMENT FOR THE NEXT WEEK. RPTR HAD SURGERY TO CLEAN UP THE "MESS" LEFT FROM BEING "BURNED UP" BY THE PROSTATRON. DR'S REPORT ON THE PROSTATRON PROCEDURE STATES THAT RPTR RECEIVED ABOUT 129 KILOJOULES OF ENERGY. RPTR SHUDDERS TO THINK WHAT SHAPE THEY COULD HAVE BEEN IN, HAD THEY RECEIVED THE FULL AMOUNT. NEEDLESS TO SAY, RPTR IS VERY BITTER, HAVING SUFFERED THROUGH THIS PROCESS THAT RPTR WAS TOLD WOULD "LAY ME UP FOR ABOUT A WEEK". RPTR DEFINITELY WOULD NOT RECOMMEND THIS TO ANYONE, AND FEELS IT SHOULD BE TAKEN OFF THE MARKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTATRON THERMOTHERAPY MACHINE MEQ EDAP TECHNOMED, INC. NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO