MAUDE Adverse Event Report: AMS WORLD HEADQUARTERS ULTREX PENILE PROSTHESIS; NONE

Model Number 700 LGX PP

Device Problem Device Inoperable (1663)

Patient Problem Urinary Frequency (2275)

Event Date 03/11/2014

Event Type  Injury  

Event Description

The patient is status post placement of penile prosthesis.The device became non-functional and the patient elected to have it replaced.The ultrex mesh completely fused with the corporal wall and was very difficult to separate the corporal wall from the mesh and so significant segments of the corporal wall were destroyed in removing the prosthesis.

• Brand Name: ULTREX PENILE PROSTHESIS
• Type of Device: NONE
• Manufacturer (Section D): AMS WORLD HEADQUARTERS; 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 3735319
• MDR Text Key: 16448914
• Report Number: 3735319
• Device Sequence Number: 1
• Product Code: FAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/28/2014

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: Other
• Device Model Number: 700 LGX PP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2014
• Distributor Facility Aware Date: 03/24/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 73