BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS CX

    MDR report key: 3788169 · Received April 24, 2014

    Report

    Report Number
    3788169
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    January 22, 2014
    Report Date
    April 24, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS INC
    Product Code
    JCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED WITH ORGANIC ERECTILE DYSFUNCTION AS A SURGICAL PATIENT FOR REPLACEMENT OF AN INFLATABLE PENILE PROSTHESIS THAT HAD LOST FLUID AND DOES NOT FUNCTION. THE ORIGINAL DEVICE WAS PLACED APPROXIMATELY FOUR YEARS AGO AT ANOTHER FACILITY. THE ORIGINAL DEVICE WAS PLACED THROUGH A PENOSCROTAL APPROACH. PATIENT HAD SURGERY TO EXPLANT THE MALFUNCTIONING DEVICE AND REPLACE IT USING AN INFRAPUBIC APPROACH. THE PATIENT WAS DISCHARGED TO HOME ON POST-OP DAY 2 WITH NO COMPLICATIONS. DEVICE WAS SAVED BY THE HOSPITAL FOR INVESTIGATION BY AMS.====================== MANUFACTURER RESPONSE FOR INFLATABLE PENILE PROSTHESIS, AMS 18 CM CX PENILE PROSTHESIS (PER SITE REPORTER).====================== AMS REP WAS PRESENT DURING THE REMOVAL OF THE MALFUNCTIONING DEVICE.PRODUCT WILL BE RELEASED TO AMS FOR INVESTIGATION OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249503 AMS CX PROSTHESIS, PENIS, INFLATABLE JCW AMERICAN MEDICAL SYSTEMS INC 700 CX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR