BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2772417 · Received August 28, 2012

    Report

    Report Number
    2772417
    Event Type
    Malfunction
    Date Received
    August 28, 2012
    Date of Event
    August 22, 2012
    Report Date
    August 28, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PROSTHESIS, PENILE FAE AMERICAN MEDICAL SYSTEMS, INC. 72401850 7543040

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR