MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, LLC (BOSTON SCIENTIFIC); PROSTHESIS, PENIS, INFLATABLE

Device Problem Extrusion (2934)

Patient Problem No Code Available (3191)

Event Date 08/02/2017

Event Type  malfunction  

Event Description

Patient was admitted from nursing home with a penile implant exposed, without pain or tenderness.Left cylinder of the device was extruded through the urethral meatus.Surgeon noted that it appeared as if the implant was placed through a penis/scrotal incision.Surgeon explanted both cylinders.The device appeared to be a 2-piece inflatable penile prosthesis of an unknown brand placed elsewhere years ago.There was a corporal defect just inside the meatus from the eroded implant.Meatus wound was irrigated, but not closed because the patient has a suprapubic tube, which was changed during the same surgery.Penis scrotal wound was closed.Patient tolerated the procedure and there were no complications.Patient was discharged to nursing home on post-op day 2 in stable condition.Manufacturer response for inflatable penile prosthesis, (per site reporter): manufacturer will investigate the cause when the device is returned.

• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, LLC (BOSTON SCIENTIFIC); 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 6791364
• MDR Text Key: 82593055
• Report Number: 6791364
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 90 YR