BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    MDR report key: 3840322 · Received May 30, 2014

    Report

    Report Number
    2183959-2014-00186
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FHW
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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

    IT WAS REPORTED THAT DURING AN IPP IMPLANT PROCEDURE ON (B)(6) 2014 THERE WERE ISSUES WITH THE KEITH NEEDLE USED DURING IMPLANT. IT WAS INDICATED THAT THE "EYE" PORTION OF THE KEITH NEEDLE BROKE OFF AND WAS RETRIEVED AND REMOVED FROM THE PATIENT BY THE PHYSICIAN. IT WAS INDICATED THAT THE PATIENT WAS IMPLANTED WITH AN 18CM LGX AFTER THE BROKEN PIECE OF THE KEITH NEEDLE WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED IN ASSOCIATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318337 AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention