BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 4074232 · Received September 9, 2014

    Report

    Report Number
    2183959-2014-00393
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FHW
    PMA / PMN Number
    N970012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 ON A CUSTOMER COMPLAINT FORM THAT DURING AN IPP IMPLANT SURGERY THE KEITH NEEDLE BROKE IN HALF. IT WAS INDICATED THAT THE NEEDLE WAS PUSHED OUT OF THE FURLOW INSERTER TOOL THROUGH THE TIP OF THE PENIS AND WHEN THE PHYSICIAN CLAMPED ONTO THE NEEDLE TO PULL IT OUT THE NEEDLE BROKE. THE PHYSICIAN WAS ABLE TO USE ANOTHER NEEDLE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553983 AMS INFLATABLE PENILE PROSTHESIS DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR