BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    MDR report key: 3916696 · Received July 7, 2014

    Report

    Report Number
    2183959-2014-00277
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FHW
    PMA / PMN Number
    N970012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE KEITH NEEDLES BROKE IN HALF WHEN THE SURGEON PASSED IT THROUGH THE FURLOW INSERTER TOOL. THIS OCCURRED DURING AN INFLATABLE PENILE PROSTHESIS IMPLANT ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT HAD A GOOD OUTCOME, NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394511 AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1