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

Model Number 72404230

Patient Problem Failure of Implant (1924)

Event Date 10/18/2023

Event Type  malfunction  

Event Description

Patient reported to provider his penile implant (ipp) had malfunctioned/stopped working.Review of ehr is limited with no date of original implant.

• 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 01752
• MDR Report Key: 18476792
• MDR Text Key: 332452431
• Report Number: 18476792
• 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
• 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
• 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: 28470 DA
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Race: White