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

Model Number 72401850

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Incontinence (1928); Pain (1994); Discomfort (2330)

Event Date 08/27/2019

Event Type  malfunction  

Event Description

Male patient reported increasing discomfort and pain with this implanted device.He reported it functional, but the cylinders were very uncomfortable; especially at the tip.He also suffered from severe incontinence post prostatectomy, which occurred after the implant was placed.The device was removed for pain management.

• Brand Name: AMS 700 ACCESSORY KIT
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 8974480
• MDR Text Key: 156923192
• Report Number: 8974480
• Device Sequence Number: 1
• Product Code: JCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/22/2019,09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 72401850
• Device Lot Number: 936045024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2019
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Weight: 98