MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS PENILE PROSTHESIS

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 04/21/2014

Event Type  Injury  

Event Description

Penile prosthesis fluid loss at the cylinder.

• Brand Name: PENILE PROSTHESIS
• Type of Device: PENILE PROSTHESIS
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS; 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 3777530
• MDR Text Key: 4432746
• Report Number: MW5035806
• Device Sequence Number: 1
• Product Code: FAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR