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 Incontinence (1928)

Event Type  Injury  

Event Description

It was reported the patient had a thermatrx procedure approximately "2 years ago." now the patient claims he has become incontinent.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: 3885461
• MDR Text Key: 18574821
• Report Number: 2183959-2014-00238
• 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: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2014
• 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