AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPY 72404311R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-11-10 for AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPY 72404311R manufactured by American Medical Systems (mn).

Event Text Entries

[5050392] It was reported that the console temperature went beyond the prescribed temperature and caused discomfort to the patient. It was also indicated that some patients needed a catheter to be inserted after treatment due to urinary retention. No additional patient complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5


[12464294] The console in question was returned for evaluation. Analysis results indicate the console performed within specification.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183959-2014-00509
MDR Report Key4241428
Report Source05
Date Received2014-11-10
Date of Report2014-10-14
Date of Event2014-10-06
Date Mfgr Received2014-10-14
Device Manufacturer Date2014-04-01
Date Added to Maude2014-11-10
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 ContactMRS. SHARON ZURN
Manufacturer Street10700 BREN ROAD W
Manufacturer CityMINNETONKA MN 55343
Manufacturer CountryUS
Manufacturer Postal55343
Manufacturer Phone9529306000
Manufacturer G1AMERICAN MEDICAL SYSTEMS (MN)
Manufacturer Street10700 BREN ROAD W
Manufacturer CityMINNETONKA MN 55343
Manufacturer CountryUS
Manufacturer Postal Code55343
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAMS THERMATRX TMX-3000 OFFICE THERMOTHERAPY
Generic NameSYSTEM, HYPERTHERMIA, RF/MICROWAVE (BPH), THERMOTHERAPY
Product CodeMEQ
Date Received2014-11-10
Returned To Mfg2014-10-28
Catalog Number72404311R
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAMERICAN MEDICAL SYSTEMS (MN)
Manufacturer Address10700 BREN ROAD W MINNETONKA MN 55343 US 55343


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2014-11-10

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