MAUDE MDR 2822389

MDR report key: 2822389
Report number: 2133936-2012-00004
Event key: 0
Event type: 3
Date of event: 2012-04-11
Date received: 2012-06-20
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 1
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Contact: MS GEORGIANNE KEYPORT
Address: 14405 TWENTY-FIRST AVE. NORTH MINNEAPOLIS MN 55447 US
Phone: 763-763-7634
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	TARGIS SYSTEM	MICROWAVE DELIVERY SYSTEM	UROLOGIX, INC.	MEQ							N	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2012-06-20	0	1. H

Event Narratives#

D

Patient 1

PATIENT HAD BECOME UROSEPTIC AND WAS ADMITTED INTO THE HOSPITAL AND DIAGNOSED WITH BACTERIAL PROSTATITIS.

N

Patient 1

AE BEGAN AFTER PROCEDURE AND DISPOSABLE CATHETER WAS DISPOSED OF AFTER PROCEDURE.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
07350081910013	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910020	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910037	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910044	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910051	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910068	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910075	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910082	CoreTherm	Prostalund AB	MEQ	2016-03-07
M876PT10340	Targis	Urologix LLC	MEQ	2014-09-26
M876PT10360	Targis	Urologix LLC	MEQ	2014-09-26
M876PT10380	Targis	Urologix LLC	MEQ	2014-09-26
M876RB3131A1	Targis	Urologix LLC	MEQ	2014-09-26
M876RB3131A2	Targis	Urologix LLC	MEQ	2014-09-26

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
PMA	P010055S011	MEQ	ProstaLund CoreTherm System Microwave Thermotherapy for BPH	Prostalund AB	2021-06-30
PMA	P030006S028	MEQ	Prolieve Thermodilation System	Medifocus, Inc.	2018-11-21
PMA	P970008S065	MEQ	UROLOGIX TARGIS SYSTEM	Urologix, LLC	2015-10-29
PMA	P970008S064	MEQ	UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH	Urologix, LLC	2015-08-28
PMA	P030006S027	MEQ	PROLIEVE THERMODILATATION SYSTEM	Medifocus, Inc.	2014-12-16