MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS MS GENIAL IMPLANT; PROSTHESIS, PENIS, INFLATABLE

Model Number AMS 700

Device Problem Inflation Problem (1310)

Patient Problem Pain (1994)

Event Date 04/23/2019

Event Type  malfunction  

Event Description

I had the second ams ms pump installed.(b)(6) i had to have the pump replaced because it quit inflating.The complete implant was replaced on (b)(6) 2019 and i did what the doctor told me to do and pumped it up three to four times a day with no sex at all.One day i went to inflate it and the bulb stayed flat, it would not take in the fluid.The doctor replaced the pump only on (b)(6) 2019 and because he had to cut the lines the pump is high up and has been hurting ever sense.I see the doctor on (b)(6) i've had three surgeries in 7 months and i am asking for him to remove it completely this time it hurts too bad for me to keep in.Device failed to inflate.(b)(4).

• Brand Name: AMS MS GENIAL IMPLANT
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.
• MDR Report Key: 8842800
• MDR Text Key: 152922854
• Report Number: MW5088503
• Device Sequence Number: 1
• Product Code: JCW
• Combination Product (y/n): N
• 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: 07/25/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AMS 700
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 90