TARGIS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-01 for TARGIS manufactured by Urologix.

Event Text Entries

[2424799] A urologist using urologix targis equipment performed a microwave heat treatment on my prostate to reduce the size of my prostate. He inserted a device in my penis and my rectum and applied the heat for about 30 minutes. Two weeks later, i complained that i could not get an erection or ejaculate. The dr laughed it off and said it's all in my head and i will get better. I did not get better. Ten years later, i cannot get an erection or ejaculate. Before the procedure i asked him 2 or 3 times are there any risk factors or side effects from the procedure. He said none, zero. I said any risk of sexual dysfunction he said none, zero. I have read about the injuries people have suffered from your files and it is horrible. Death, fistulas, bleeding, incontinence, erectile damage, hospitalization. I believe the risk factors in this procedure are understated. What you have in your files is the tip of the iceberg. I believe many cases are never reported to you. I complained to my dr. I don't believe it was reported to the fda, hosp or the mfr. Important! The reason i am late in reporting this i was to too devastated, angry and embarrassed to talk about this. After going on your site and reading all about the people that were injured by the urologix targis equipment, death, fistulas, sexual organ damage, severe bleeding, hospitalization and other injuries i had to speak up. I believe these injuries reported are just the tip of the iceberg. The risk factors on this procedure are very understated and a lot more people are going to get hurt. The reason i don't want the mfr to have my name i don't want to get sued. I am telling the truth there is no reason i would lie about this.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5024130
MDR Report Key2440533
Date Received2012-02-01
Date of Report2012-02-01
Date of Event2001-01-15
Date Added to Maude2012-02-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTARGIS
Generic NameUROLOGIX TARGIS EQUIPMENT
Product CodeMEQ
Date Received2012-02-01
Device Sequence No1
Device Event Key0
ManufacturerUROLOGIX


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-02-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.