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

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

Patient Problem Pain (1994)

Event Date 10/06/2014

Event Type  Injury  

Event Description

It was reported by the patient that he experienced "agonizing pain" during his 50 minute procedure.No additional patient complications were reported in relation to this event.

• 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: 4194825
• MDR Text Key: 20974606
• Report Number: 2183959-2014-00471
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other