THERMATRX RX20045C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-02-22 for THERMATRX RX20045C manufactured by American Medical Systems, Inc..

Event Text Entries

[2521632] Info was received indicating that the 4. 5cm catheter used for the thermatrx treatment on (b)(6) 2012 seemed wider than usual. The info indicated that the catheter was wider at the coil area and the insertion into the pt was more difficult. On completion of the procedure the pt's meatus appeared stretched. On (b)(6) /2012 at a follow up visit, urethral strictures were found and treated with dilatation. Report indicates the pt is doing well.
Patient Sequence No: 1, Text Type: D, B5


[9656505] Should add'l info become available regarding this revision surgery it will be re-evaluated and a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183959-2012-00148
MDR Report Key2473800
Report Source05,07
Date Received2012-02-22
Date of Report2012-01-26
Date of Event2012-01-26
Date Mfgr Received2012-01-26
Date Added to Maude2012-03-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJON CORNELL, SR MGR
Manufacturer Street10700 BREN RD., WEST
Manufacturer CityMINNETONKA MN 55343
Manufacturer CountryUS
Manufacturer Postal55343
Manufacturer Phone9529306670
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTHERMATRX
Generic NameTHERMAL TREATMENT SYSTEM
Product CodeMEQ
Date Received2012-02-22
Catalog NumberRX20045C
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAMERICAN MEDICAL SYSTEMS, INC.
Manufacturer Address10700 BREN RD., WEST MINNETONKA MN 55343 US 55343


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2012-02-22

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