BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    MDR report key: 3631940 · Received February 18, 2014

    Report

    Report Number
    2183959-2014-00041
    Event Type
    Injury
    Date Received
    February 18, 2014
    Report Date
    January 30, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FHW
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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

    RELATED TO MFR REPORT NO. 2183959-2014-00039 & 2183959-2014-00040. IT WAS REPORTED THAT THE PATIENT EXPERIENCED "LONG TERM PAIN" INDICATING INHIBIZONE MAY BE SUSPECT. ADDITIONAL OBSERVATIONS INCLUDE: POST OPERATIVE REDNESS, TENDERNESS AND SWELLING. THERE WERE NO SIGNS OF INFECTION AND THE DEVICE REMAINS IMPLANTED. NO FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103425 AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention