MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS INC. AMS INFLATABLE PENILE PROSTHESIS

Device Problems Degraded (1153); Material Erosion (1214)

Patient Problem Inflammation (1932)

Event Date 04/15/2015

Event Type  malfunction  

Event Description

Patient was admitted by urologist for removal (explant) of an inflatable penile prosthesis that was not implanted at our hospital.The prosthesis eroded into the right corpora, distal urethra and bulbar urethra.It was implanted by another surgeon several years ago.Inflammation of tissue was noted during the surgery to remove the device.No prosthesis was replaced when the eroded prosthesis was removed.Surgeon placed a urethral foley catheter and suprapubic tube for drainage and repaired the urethra surgically.Patient did well post-operatively and was discharged to home the next day.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS INC.; 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 4855820
• MDR Text Key: 5807318
• Report Number: 4855820
• Device Sequence Number: 1
• Product Code: JCW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2015
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 57 YR
• Patient Weight: 111