MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS 700 SPHERICAL RESERVOIR WITH INHIBIZONE; PROSTHESIS, PENIS, INFLATABLE

Model Number 72404155

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2017

Event Type  malfunction  

Event Description

A penile prosthesis was removed due to a cylinder rupture 3 years post implantation.Replacement procedure was performed without complication and patient was discharged home the following day.

• Brand Name: AMS 700 SPHERICAL RESERVOIR WITH INHIBIZONE
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 7137670
• MDR Text Key: 95527941
• Report Number: 7137670
• Device Sequence Number: 1
• Product Code: JCW
• UDI-Device Identifier: 00878953003207
• UDI-Public: (01)00878953003207
• 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: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 72404155
• Device Catalogue Number: 72404155
• Device Lot Number: 880258007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2017
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 93