FDA Adverse Event Injury Summary report: N

PROSTATRON - TUMT

MDR report key: 208964 · Received February 4, 1999

Report

Report Number
MW1015613
Event Type
Injury
Date Received
February 4, 1999
Date of Event
December 30, 1997
Report Date
January 10, 1999
Manufacturer
EDAP TECHNOMED INC.
Product Code
MEQ
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IL, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

RPTR WRITES, "AFTER READING ADVERTISEMENTS AND APPROVAL BY THE FDA, I LET A DR PRACTICE ON ME WITH THE KILLING MACHINE, PROSTATRON. HE COULD NOT CONTROL IT. WITHOUT A CYSTOSCOPE, HE EXAMINED ME AND KNEW MY PROSTATE WAS ENLARGED 4 TIMES. IT WENT WRONG, CUT UP MY PROSTATE, CUT MY URETHRA IN HALF, AND BURNED IT. IT CHOPPED UP MY PROSTATE WITH BLOOD CLOTS THAT TOOK 3 MONTHS TO WORK THROUGH MY PENIS AND BLADDER. I WAS IN HIS OFFICE ONCE A WEEK, REMOVING CATHETER BY INTERN. DR WAS NOT AVAILABLE (MALPRACTICE) 3 TIMES IN EMERGENCY ROOM AT HOSPITALS. AT 4-5 AM IN PAIN, COMATOSE. NO DR WANTS ANYTHING TO DO WITH THIS TROUBLE BY DR TWO AND A HALF MONTHS LATER (MARCH 26, 1998), ANOTHER DR SAVED MY LIFE WITH A TRANSURETHRAL RESECTION OF PROSTATE. THIS DR TOOK CYTOSCOPE PICTURES ON MARCH 27, 1998 AND SAID WHAT DID THIS MAN DO TO YOU AND OPERATED. SUMMATION: 1. THIS MACHINE IS A KILLING ONE. 2. IN THE HANDS OF AN INCOMPETENT UROLOGIST, IT ALMOST KILLED ME. 3. DRS BURY THEIR MISTAKES! I WAS LUCKY. WHEN YOU TRUST YOUR DR AND HE SAYS HE WILL OPERATE IN HIS OFFICE, NO PAIN, NO CUTTING SURGERY, NO HOSPITALIZATION (2 PILLS - 1 SHOT - THEY DID NOT WORK). I WAS AWAKE FOR TWO HOURS - ALL THROUGH THE OPERATION. 4. I WAS TOLD TO TAKE OFF MY CLOTHES, AND TO PUT ON A SHEET BY AN INTERN OR DOCTOR'S HELPER. (HE WAS THE ONLY ONE THAT I HAD CONTACT WITH BESIDES THE DR IN THE OFFICE FOR TWO MONTHS.) 5. I LAY ON THE TABLE FOR ONE HOUR LISTENING TO MUSIC. THE SECOND HOUR HE PUT A CATHETER IN MY PENIS AND URETHRA TO MY BLADDER TO URINATE. (THIS WAS THE FIRST TIME IN MY LIFE I HAVE HAD A CATHETER AND I HAD ONE IN FOR THREE MONTHS. ONCE A WEEK I HAD ONE IN FOR THREE MONTHS TO OPEN MY BLADDER TO URINATE OR I WOULD DIE FROM UREMIC POISONING - SUCH PAIN. 6. DR REMOVED THE CATHETER AND INSERTED THE MICROWAVE TUBE THROUGH MY PENIS INTO MY URETHRA AND BLADDER. I ROLLED ON MY SIDE AND (I THOUGHT IN THE DARK) ANOTHER DR INSERTED A SMALL (BASEBALL BAT) CAMERA INTO MY RECTUM - IT HURT. THEY AGREED MY PROSTATE WAS ENLARGED (NO CANCER?). 7. HE THEN SAT DOWN ALONGSIDE OF ME WITH HIS KILLING MACHINE. 8. FOR ONE HOUR HE RAN THE MICROWAVE MACHINE IN MY URETHRA. IT HEATED UP AND IT HURT. WHAT CAN YOU DO WITH THIS THING BURNING YOUR INSIDES? 9. I HEARD HIM SAY "BOY, THIS IS BIG. I MAY HAVE TO DO IT AGAIN". 10. I TOLD HIM I WAS IN PAIN. HE SAID ONLY TWENTY MINUTES MORE. SUCH TORTURE - LIKE GETTING A TOOTH PULLED WITH NO ANESTHESIA. 11. I WAS ON THE TABLE FROM 1 P.M. UNTIL 3:30 P.M. HE REMOVED THE TUBE AND THE DR INSERTED A CATHETER - I COULD NOT URINATE. 12. THE INTERN SAID GO HOME AND COME BACK MONDAY AND I WILL TAKE OUT THE CATHETER, YOU'LL SEE ME. DRINK EIGHT GLASSES OF WATER A DAY. 13. I CALLED AND ASKED FOR TWO MONTHS AND NEVER SAW THE DR ONLY THE INTERN. 14. I RETURNED MONDAY AND ASKED FOR THE DR, HE WAS NOT AVAILABLE. THE INTERN SAID, "I WILL TAKE CAR OF YOU FROM NOW ON." 15. HE REMOVED THE CATHETER AND SAID GO EAT AND TRY TO URINATE. I RETURNED AND COULD NOT URINATE. THE INTERN REINSERTED THE CATHETER AND BAG AND SAID GO HOME AND COME BACK NEXT WEEK. I CAME BACK AT THE END OF THE WEEK (4 O'CLOCK IN THE MORNING) TO THE OFFICE (IT OPENED AT 7:30) IN PAIN. URINE HAD BACKED UP INTO MY BLADDER. 16. SMALL BLOOD CLOTS FROM THE KILLING MACHINE HAD PLUGGED THE CATHETER IN MY BLADDER. 17. SOME BLOOD CLOTS TRIED TO COME OUT AROUND THE CATHETER AND CAME OUT OF MY PENIS - ABOUT A TABLESPOON A DAY FOR TWO MONTHS. 18. THIS RITUAL CONTINUED FOR THREE MONTHS (4 O'CLOCK IN THE MORNING - WAKE UP-CAN'T URINATE - CATHETER PLUGGED WITH BLOOD CLOTS FROM THE KILLING MACHINE - DRIVE TO THE HOSP IN PAIN - LEGS NUMB - WAIT FOR DR - TAKE OUT CATHETER-FLUSH OUT BLADDER - RELIEF AND A NEW CATHETER TAKE CONTROL - AFRAID OF UREMIC POISONING. THE INTERN SAID BAD POSSIBILITY. DID DR WANT ME TO DISAPPEAR OR DIE? (HIS MISTAKE). 19. THIS WENT ON EVERY WEEK FOR THREE MONTHS. WHY AM I ALIVE? THE INTERN SAID IF AT NIGHT I'M PLUGGED UP AND IN PAIN TO GO TO ANY HOSP EMERGENCY ROOM. THE DR THERE SAID I CAN'T DO ANYTHING EXCEPT FOR THE UROLOGIST'S DIRECTIONS. FINALLY, THEY REMOVED THE CATHETER - BEAUTIFUL RELIEF. THE CATHETER WAS PLUGGED UP WITH BLOOD CLOTS. THEY PUT IN A NEW CATHETER AND I WAS OKAY FOR A COUPLE OF DAYS AND REPEAT - PLUGGED UP. DR WAS NOT AVAILABLE. HE KNEW THROUGH THE INTERN, HIS MISTAKE. IF I WOULD JUST DIE OR GO AWAY - FINE. THE CHUNKS OF BLOOD STICK IN THE PROSTATE AND LEAK OUT SLOWLY. I WAS CLOSE TO DEATH MANY TIMES IN THE NEXT THREE MONTHS FROM UREMIC POISONING-URINE BACKING UP IN THE BLADDER. WHY DOES THE PROSTATON NOT WORK? 1. THE DR CANNOT SEE WHERE IT GOES. 2. HE CANNOT CONTROL IT WITHOUT SEEING WHERE IT GOES. 3. IT BURNS AND LIKE THE MICROWAVE OVEN, CHOPS UP THE TISSUE INTO SMALL BLOOD CLOTS. IT CANNOT FLUSH OUT THE CLOTS. 4. IT PLUGS UP THE CATHETER, URETHRA AND SPHINCTER VALVES. 5. THE EIGHT GLASSES OF WATER A DAY CANNOT COME THROUGH. 6. YOU ARE PLUGGED UP AT 4 A.M. AND IN PAIN. THERE IS NO RELIEF. PLEASE STOP THIS PROSTATON AND DR. I WAS A LAY PERSON ABOUT UROLOGY FOR THOSE TWO TO THREE MONTHS. I DID NOT KNOW WHAT HAD BEEN DONE TO MY INSIDES. IF YOU ONLY KNEW WHAT IT WAS LIKE TO BE ALL ALONE AT 4 O'CLOCK IN THE MORNING IN PAIN WITH NO ONE TO ADVISE YOU OR TO CORRECT THE PROBLEM. I HAD NO DR TO HELP OR ADVISE ME-JUST AN INTERN. THAT WAS UNTIL MARCH OF 1998 WHEN I FOUND ANOTHER DR. HE SAID HE COULD HELP ME AND WOULD. HE SAVED MY LIFE. IN THE TRANS-URETHRAL RESECTION OF THE PROSTATE OPERATION THAT I HAD (THAT SAVED MY LIFE AFTER THREE MONTHS OF SUFFERING) - ONE DAY IN THE HOSP-MY PROSTATE WAS REAMED OUT LEAVING A SHELL (FLUSHED OUT UNDER OBSERVATION AND UNDER ANESTHESIA USING A CYSTOSCOPE. THERE WAS NO PAIN. FOUR DAYS LATER, THE CATHETER WAS REMOVED AND, AS PROMISED, I HAVE BEEN URINATING (WIDE OPEN) FOR NINE MONTHS - SINCE TRANS-URETHRAL RESECTION OF THE PROSTATE. THANK YOU LORD AND DR. HE SAVED MY LIFE WITH TRANS-URETHRAL RESECTION OF THE PROSTATE."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PROSTATRON - TUMT HEAT-MICROWAVE-DESTROY PROSTATE MEQ EDAP TECHNOMED INC. UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 76 YR Hospitalization| L| R