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

Model Number 72404230

Patient Problems Failure of Implant (1924); Urinary Tract Infection (2120)

Event Date 11/06/2023

Event Type  malfunction  

Event Description

Patient had a penile implant (ipp) implanted over 12 years ago.Recent medical history shows recurrent urinary tract infection (uti).Urology consult found an erosion of the left cylinder through the urethral meatus.No other disfunction of the device is mentioned in the limited documentation in his electronic medical record.

• Brand Name: AMS 700 CX MS PUMP
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 300 boston scientific way; marlborough, ma MA 01752
• MDR Report Key: 18476816
• MDR Text Key: 332452806
• Report Number: 18476816
• 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: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 72404230
• Device Catalogue Number: AMS 700 CX PENILE PROSTHESIS 3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2023
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32485 DA
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: White