BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    MDR report key: 4074290 · Received September 9, 2014

    Report

    Report Number
    2183959-2014-00392
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 15, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FHW
    PMA / PMN Number
    N970012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE KEITH NEEDLES BROKE DURING AN IPP IMPLANT PROCEDURE. THE KEITH NEEDLE WAS USED IN THE FURLOW INSERTION TOOL, WHEN THE NEEDLE WAS PUSHED OUT OF THE TIP OF THE PATIENT'S PENIS THE PHYSICIAN WENT TO CLAMP THE NEEDLE TO PULL IT OUT AND THE NEEDLE BROKE. HALF OF THE NEEDLE REMAINED IN THE FURLOW INSERTION TOOL. THE PHYSICIAN WAS ABLE TO USE THE OTHER NEEDLE WITHOUT ISSUE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554451 AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR