BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    MDR report key: 4056459 · Received September 3, 2014

    Report

    Report Number
    2183959-2014-00387
    Event Type
    Malfunction
    Date Received
    September 3, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 14, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FHW
    PMA / PMN Number
    N970012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED: COMMON DEVICE NAME FROM PENILE PROSTHESIS TO DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC. PRODUCT CODE (FDA) FROM FAE TO FHW. THE PMA/510(K) FROM K821628 TO N970012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AMS700 PENILE PROSTHESIS IMPLANT PROCEDURE THE KEITH NEEDLE BROKE IN HALF AS IT WAS BEING EXTRACTED FROM THE END OF THE FURLOW INSERTER TOOL AFTER CYLINDER INSERTION. BOTH PIECES OF THE NEEDLE WERE REMOVED AND THE AMS700 DEVICE WAS SUCCESSFULLY IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT AND THE PATIENT'S STATUS FOLLOWING THE PROCEDURE WAS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536931 AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR