MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS UROLUME ENDOPROSTHESIS; STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

It was reported by the patient that he recently had his urolume stent removed.The reason for the stent removal was not provided.Additional information indicates that approximately two months after stent removal, a surgery was performed to install a bladder drain.There were four additional wires from the urolume that were found and removed during the bladder drain surgery.No further patient complications were reported in relation to this event.

• Brand Name: AMS UROLUME ENDOPROSTHESIS
• Type of Device: STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
• 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: 3622947
• MDR Text Key: 20324951
• Report Number: 2183959-2014-00022
• Device Sequence Number: 1
• Product Code: MES
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P920023
• 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: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 02/11/2014
• 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): Required Intervention