MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS 700 CX MS PUMP IZ/PRECONNECTED - INFRAPUBIC; PROSTHESIS, PENIS, INFLATABLE

Model Number 72404236

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); No Code Available (3191)

Event Date 06/21/2017

Event Type  malfunction  

Event Description

Patient had an ams penile prosthesis.Overnight, the patient experienced complications.It was discovered that the prosthesis had eroded into the patient's urethra.A catheter was inserted to relieve patient.Ultimately, the prosthesis was removed on next day.The explanted device was given to manufacturer representative for investigations.No lasting effects on patient.Alternate implant options will be discussed at a future time.Manufacturer rep retrieved the device for further investigation.

• Brand Name: AMS 700 CX MS PUMP IZ/PRECONNECTED - INFRAPUBIC
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 6749885
• MDR Text Key: 81358640
• Report Number: 6749885
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 72404236
• Device Lot Number: 165672002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 83