FDA Adverse Event Injury Summary report: N

TARGIS

MDR report key: 756791 · Received August 30, 2006

Report

Report Number
MW1040244
Event Type
Injury
Date Received
August 30, 2006
Date of Event
September 15, 2004
Report Date
August 30, 2006
Manufacturer
UROLOGIX, INC.
Product Code
MEQ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

A SALESMAN FOR UROLOGIX, INC. USED THE TARGIS MEDICAL DEVICE ON ME IN A DOCTOR'S OFFICE. THE SALESMAN, WHOM THE DOCTOR INTRODUCED TO ME AS A TECHNICIAN WHILE I WAS ON THE OPERATING TABLE, WAS WEARING STREET CLOTHES AND WAS NOT AUTHORIZED EITHER BY HIS EMPLOYER, UROLOGIX, INC. OR BY LAW, TO DO THE OPERATION, WHICH WAS INTENDED TO REDUCE THE SIZE OF MY PROSTATE. DR, WHO HAD NEVER DONE THE TARGIS PROCEDURE BEFORE AND WAS NOT CERTIFIED BY UROLOGIX UNTIL THE FOLLOWING MONTH, MERELY STOOD BY AS THE SALESMAN HANDLED THE CONTROLS ON THE DEVICE. THE OPERATION NOT ONLY WAS A COMPLETE FAILURE BECAUSE IT DID NOT REDUCE MY PROSTATE ONE IOTA, BUT IN THE WEEKS THAT FOLLOWED, I SUFFERED EXCRUCIATING PAIN, EFFUSIVE BLEEDING AND LIFE-THREATENING INFECTION, WHICH DR REFUSED TO TREAT BECAUSE HE CALLED THESE SYMPTOMS "A GOOD SIGN" THAT THE OPERATION WAS A SUCCESS. HE ATTRIBUTED THEM TO MY "OLD BLOOD." I WAS TREATED THREE TIMES IN HOSPITAL EMERGENCY ROOMS AND ONCE, MY WHOLE BODY SHAKING FROM FEVER, I WAS RUSHED BY AMBULANCE TO THE HOSPITAL FOR MORE ADVANCED TREATMENT. THEREAFTER, A CANCER GREW ON MY ABDOMEN TO EIGHT TIMES THE DEPTH FOR LIKELY METASTASIS. IT WAS REMOVED IN TWO OPERATIONS AT THE HOSP. BUT BECAUSE OF ITS SIZE AND DEPTH, THE CANCER MAY RETURN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TARGIS TARGIS MEQ UROLOGIX, INC. TARGIS *

Patients

Seq Age Sex Outcome Treatment
1 72 YR Hospitalization| L| O| R| S