BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS MALLEABLE 600/650 PENILE PROSTHESIS

    MDR report key: 2192448 · Received July 27, 2011

    Report

    Report Number
    2183959-2011-00279
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    May 6, 2011
    Report Date
    March 28, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CYLINDERS INVOLVED IN THIS EVENT WERE RETURNED FOR ANALYSIS. THE CYLINDERS WERE RATED AS PERFORMING WITHIN SPECIFICATION. NO MECHANICAL FAILURE WAS NOTED.

    Description of Event or Problem · 1

    A MALLEABLE PENILE PROSTHESIS DEVICE WAS IMPLANTED, DETAILS WERE NOT PROVIDED. ON (B)(6) 2011, AMS WAS NOTIFIED THAT A REVISION SURGERY WAS NEEDED FOR THIS PT. ON (B)(6) 2011, THE ENTIRE DEVICE WAS REMOVED AND REPLACED DUE TO A "MECHANICAL FAILURE." NO PT COMPLICATIONS REPORTED. AMS HAS REQUESTED ADDITIONAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS MALLEABLE 600/650 PENILE PROSTHESIS PENILE PROSTHESIS FAE AMERICAN MEDICAL SYSTEMS, INC. 650

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R