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

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

Patient Problems Dysuria (2684); No Code Available (3191)

Event Date 07/01/2015

Event Type  Injury  

Event Description

It was reported the patient's urolume stent was removed because the patient was unable to properly urinate or ejaculate.With the stent removed, the patient can void properly without pain.No additional 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: 5103866
• MDR Text Key: 26747563
• Report Number: 2183959-2015-00403
• 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
• Report Date: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 86 YR