MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS 700 PENILE PROSTHESIS; PROSTHESIS, PENIS, INFLATABLE

Model Number 72401850

Device Problems Kinked (1339); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 11/11/2017

Event Type  malfunction  

Event Description

Patients inflatable penile prosthesis device had issues with the pump and reservoir attachments working properly requiring a revision and replacement.Continues to kink.Patient dissatisfied with the outcome.

• Brand Name: AMS 700 PENILE PROSTHESIS
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 7463918
• MDR Text Key: 106609018
• Report Number: 7463918
• 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: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 72401850
• Device Lot Number: 146281003
• Other Device ID Number: LOG300520
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2018
• Device Age: 1 DY
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR