BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 3042223 · Received March 19, 2013

    Report

    Report Number
    3042223
    Date Received
    March 19, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 19, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD TO HAVE 3 SURGERIES IN 6 MONTHS. 1) HAD "CROSSOVER" AND THEN, 2) FLUID VALVE NOT WORKING. EXCHANGED OUT MODELS AND COMPANIES. 3) PAIN UNRESOLVED AND HAD TO BE REMOVED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?IPP 3 PIECE PROSTHESIS.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113745 * PENILE PROSTHESIS FHW AMERICAN MEDICAL SYSTEMS, INC. 72401850 810058015

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR SCAR TISSUE CAUSED DISTAL CROSSOVER