BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS 700

    MDR report key: 5982794 · Received September 28, 2016

    Report

    Report Number
    5982794
    Event Type
    Malfunction
    Date Received
    September 28, 2016
    Date of Event
    August 12, 2016
    Report Date
    September 16, 2016
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, LLC
    Product Code
    JCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ELEMENTS HAVE BLANK DATA. UNIQUE DEVICE IDENTIFIER (UDI): FOR TYPE OF DEVICE: PROSTHESIS, PENIS, INFLATABLE. DEVICE SERIAL #: FOR TYPE OF DEVICE: PROSTHESIS, PENIS, INFLATABLE. DEVICE MODEL #: FOR TYPE OF DEVICE: PROSTHESIS, PENIS, INFLATABLE. DEVICE LOT #: FOR TYPE OF DEVICE: PROSTHESIS, PENIS, INFLATABLE. DEVICE CATALOG (REF) #: FOR TYPE OF DEVICE: PROSTHESIS, PENIS, INFLATABLE.

    Description of Event or Problem · 1

    THE PENILE PROSTHESIS THAT HAD BEEN ORIGINALLY IMPLANTED IN 2002 HAD FAILED. THE PATIENT WAS TAKEN TO THE MAIN OPERATING ROOM FOR EXPLANTING OF THE MALFUNCTIONING PENILE PROSTHESIS AND REPLACEMENT WITH A NEW COLOPLAST SURGICAL (TITAN) PENILE PROSTHESIS.

    Description of Event or Problem · 1

    THE PENILE PROSTHESIS THAT HAD BEEN ORIGINALLY IMPLANTED IN 2002 HAD FAILED. THE PATIENT WAS TAKEN TO THE MAIN OR FOR EXPLANTING OF THE MALFUNCTIONING PENILE PROSTHESIS AND REPLACEMENT WITH A NEW COLOPLAST SURGICAL (TITAN) PENILE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636665 AMS 700 PROSTHESIS, PENIS, INFLATABLE JCW AMERICAN MEDICAL SYSTEMS, LLC UNKNKOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR