MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC AMS 700 PENILE PROSTHESIS

Model Number AMS 700 MS SERIES

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 01/21/2015

Event Type  malfunction  

Event Description

I have an ams 700 penile implant device.The device will not longer operate.It was installed on (b)(6) 2014.This is a poorly designed device and valve system and should not have failed in a short amount of time.The mfr should pay for replacement.

• Brand Name: AMS 700 PENILE PROSTHESIS
• Type of Device: AMS 700 PENILE PROSTHESIS
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC
• MDR Report Key: 4774366
• MDR Text Key: 5802692
• Report Number: MW5042719
• 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: Patient
• Type of Report: Initial
• Report Date: 05/05/2015

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: Lay User/Patient
• Device Model Number: AMS 700 MS SERIES
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2015
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 95