BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    MDR report key: 3871465 · Received June 13, 2014

    Report

    Report Number
    2183959-2014-00215
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FHW
    PMA / PMN Number
    N970012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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.

    Additional Manufacturer Narrative · 1

    ONE BENT NEEDLE FROM AN INFLATABLE PENILE PROSTHESIS (AMS 700) ACCESSORY KIT WAS RETURNED. THE NEEDLE IS BROKEN INTO 2 PARTS APPROXIMATELY 2.2 CM FROM THE NEEDLE POINT END. THE BREAK APPEARS TO BE THE RESULT OF FATIGUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A KEITH NEEDLE [BENT NEEDLE] BROKE WHILE INSERTING AN INFLATABLE PENILE PROSTHESIS CYLINDER. IT WAS FURTHER REPORTED THAT THE PHYSICIAN WAS ABLE TO PUSH OUT THE REMAINDER OF THE NEEDLE AND GET THE CYLINDERS IMPLANTED. THIS NEEDLE IS SUPPLIED IN THE AMS ACCESSORY KIT, LOT NUMBER WAS NOT PROVIDED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349714 AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention