BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 5009792 · Received August 18, 2015

    Report

    Report Number
    5009792
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    June 1, 2015
    Report Date
    August 11, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS INC
    Product Code
    JCW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ELEMENTS HAVE BLANK DATA

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED FOR REPLACEMENT/REVISION OF INFLATABLE PENILE PROSTHESIS THAT WAS IMPLANTED APPROXIMATELY FIVE YEARS AGO. LAST YEAR, SURGEON REPORTS THE DEVICE WAS NOT WORKING WELL AND APPROXIMATELY FOUR MONTHS AGO THIS YEAR, THE DEVICE WAS NOT FUNCTIONING AT ALL. PATIENT WAS ABLE TO ACHIEVE ERECTION, BUT IMMEDIATELY SUBSIDES AFTER PUMPING THE INFLATABLE PENILE PROSTHESIS. SURGEON NOTED APPEARANCE OF FLUID ON EXAM AND THIS IS CONSISTENT WITH A NONFUNCTIONING LOCKOUT VALVE. DEVICE WAS REMOVED AND REPLACED WITH AMS IMPLANTED DEVICE. PATIENT HAD NO POST-OP COMPLICATIONS AND WAS DISCHARGED HOME THE DAY AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543849 AMS INFLATABLE PENILE PROSTHESIS PENILE PROSTHESIS JCW AMERICAN MEDICAL SYSTEMS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other