BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROWAVE TREATMENT FOR BPH

    MDR report key: 1220673 · Received November 3, 2008

    Report

    Report Number
    MW5008847
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    November 1, 2007
    Report Date
    April 12, 2009
    Product Code
    MEQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOLLOW UP ON MICROWAVE TREATMENT FOR BPH: I AM NOW AT 6 UROLOGISTS AND TWO SURGERIES. THE SWELLING HAS REACHED 30 PLUS POUNDS AND EVERY DOCTOR SAYS IT IS FAT. FAT DOES NOT HURT TO THE POINT OF NOT BEING ABLE TO STAND ERECT OR WALK. FAT DOES NOT ACHE TO THE POINT OF SCREAMING. FAT DOES NOT FORM IN THIS MAGNITUDE IN 1 YEAR AND 4 MONTHS. I HAVE HAD A CYSTOGRAPH WITH SURGICAL WORK DONE IN THE URETHRA. I HAVE A CONSTANT PAIN THAT IS JUST ABOUT TO MAKE ME CRAZY. I DO NOT KNOW WHAT TO DO OR WHERE TO TURN NOW. I HAVE AN APPOINTMENT AT LOMA LINDA MEDICAL CENTER IN MAY, IF I MAKE IT THAT LONG. MICROWAVE TRANSMITTER DEVICE FOR BPH. IN DOCTORS OFFICE, HE HAS SEVERAL MACHINES. I WAS NEVER IN THE CLINIC PART OF THE FACILITY AGAIN, ONLY TO EXAMINING ROOMS AFTER THE TREATMENT. DIAGNOSIS: ENLARGED PROSTATE.

    Description of Event or Problem · 1

    I AM THE PATIENT, THE EVENT TOOK PLACE IN 2007. THE MICROWAVE TREATMENT WAS INITIATED BY THE PHYSICIAN AS WAS THE MAN NEXT TO ME AND THE PERSON IN THE NEXT CUBICLE. THE PHYSICIAN SET UP AND INITIATED THE TREATMENT AND WENT ON TO HIS NEXT PATIENT. A NURSE WAS LEFT TO ATTEND TO THE MACHINE AND ME. WITHIN 10 MINUTES, THE PAIN WAS SO INTENSE I WAS SCREAMING AND THE NURSE WENT TO GET THE DOCTOR WHO ADMINISTERED A PAIN INJECTION. I THINK IT WAS DEMEROL OR SOMETHING. THE PAIN WAS STILL BAD. THE PROCEDURE WAS LEFT TO RUN FOR A MAJORITY OF THE PRESCRIBED 45 MINUTES. WHEN COMPLETED, THE DOCTOR AND NURSE REMOVED THE TEMP SENSOR AND I WAS CATHETERIZED. THE CATHETER WAS LEFT IN FOR WEEKS. BLEEDING WAS COMMON DURING THIS ENTIRE TIME. THE DOCTOR PRESCRIBED FLOMAX FOR CONTINUED TREATMENT -90. AFTER THE TREATMENT AND THE REMOVAL, THE SWELLING STARTED. I RETURNED TO THE DOCTOR AND HE STATED THAT IT COULD NOT BE THE TREATMENT THAT IT MUST BE MY INTESTINES. I WENT TO MY GP. HE REFERRED ME TO A GIU DOCTOR WHICH HAD EVERY GI TEST KNOWN TO MAN PERFORMED ON ME. NOTHING. I WENT TO ANOTHER UROLOGIST. HE IS A COLLEAGUE OF THE INITIAL DOCTOR. HE SAID I MUST HAVE A HERNIA IN MY SCROTAL AREA. I WENT TO A THIRD WHO SAID I HAD A DAMAGED AREA IN MY PELVIC REGION IN THE URETHRA AT THE PROSTATE. THE SWELLING HAS CONTINUED IN MY PELVIC AND LOWER ABDOMINAL AREAS. IT GETS WORSE BY THE WEEK. I AM SWOLLEN IN MY GROIN AND LOWER ABDOMEN TO THE POINT I CAN NOT LAY ON MY SIDE, PUT ON MY SOCKS OR SIT UPRIGHT FOR ANY PERIOD OF TIME. MY URINATION IS STILL HIGHLY IMPAIRED. I HAVE GONE TO A 4TH UROLOGIST. TESTS BEGINS THIS WEEK. THAT INCLUDES MORE AND MORE CAT SCANS AND ULTRASOUNDS AND INTRA URETHRAL EXAMINATIONS. I AM TO THE POINT THAT NOTHING STOPS THE PAIN OR DISCOMFORT AND THE SWELLING IS KEEPING ME FROM BREATHING CORRECTLY OR HAVING A NORMAL BOWEL MOVEMENT. THE PROBLEMS FROM THE MICROWAVE TREATMENT ARE TEN TIMES WORSE THAT THE INITIAL PROBLEM OF BEING ABLE TO HOLD MY URINE PROPERLY OR CONTROLLING THE INSTANT URGES. I NEED HELP AND DO NOT KNOW WHERE TO TURN. THIS IS NOT NORMAL FOR ME NOT EVEN IN THE SLIGHTEST. IF IT IS POSSIBLE TO HELP ME FIND PROPER MEDICAL ASSISTANCE, I WOULD BE EXTREMELY GRATEFUL, I CANNOT TOLERATE MORE AND MORE DOCTORS TELLING ME THAT I AM FAT IN THE SCROTAL AREA AND THAT MY PENIS SHOULD BE DISAPPEARING IN TO THE SWELLING. I WOULD BE HAPPY TO SEND MY NAME AND ALL THE RELEVANT DATA AND HAVE MY DOCTORS FORWARD ALL DATA TO ANYONE THAT CAN HELP ME. I DO NOT KNOW EXACTLY WHAT YOU ARE ASKING FOR. I HAVE MY DAY BOOK WITH ALL THE PERTINENT DATES AND DOCTORS SEEN AND TESTS PERFORMED IF THAT IS WHAT YOU WANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROWAVE TREATMENT FOR BPH MEQ

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other