MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPY; SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BPH), THERMOTHERAPY

Catalog Number 72404311R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Urinary Retention (2119); Discomfort (2330)

Event Date 09/26/2014

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

The console in question was returned for evaluation.Analysis results indicate the console performed within specification.

• Brand Name: AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPY
• Type of Device: SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BPH), THERMOTHERAPY
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 4241431
• MDR Text Key: 5066634
• Report Number: 2183959-2014-00506
• Device Sequence Number: 1
• Product Code: MEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72404311R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention