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

Model Number LVL 15 INFLATABLE PENILE PROSTHESIS 72404253

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Erythema (1840); Pain (1994); Urinary Retention (2119)

Event Date 05/27/2016

Event Type  malfunction  

Event Description

Patient had an inflatable penile prosthesis placed 8 months prior to this admission.It did well until approximately 2 months ago, when patient noticed increased pain in penis, had erythema of glans, and erosion at the meatus was noted.Patient was taken to surgery for removal of the eroded 3-piece ams inflatable penile prosthesis.Surgeon noted he could see the cylinder coming through the glans and had difficulty with urination.There was erosion of the cylinder through the area on the ventral surface of the coronal sulcus where he had a prior piercing.There was no erosion into the urethra.Ipp was removed surgically.Surgeon placed a malleable semi-rigid prosthesis.No post-op complications and patient was discharged to home.Information on devices explanted: penile prosthesis 700 acc log 511124 lot #915544017 model 72401850.Penile prosthesis rear 4 cm.Log 511124 model 72404324.Penscr 21 mm log 511124 model 72404253.Conceal reservoir inhbz log 511124 model 72404253.

• 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: 5846256
• MDR Text Key: 51157044
• Report Number: 5846256
• 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: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: LVL 15 INFLATABLE PENILE PROSTHESIS 72404253
• Device Catalogue Number: LOG 511124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2016
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2016
• 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: 71 YR
• Patient Weight: 123