BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 2801006 · Received October 18, 2012

    Report

    Report Number
    2183959-2012-02907
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 24, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ON AN UNK DATE, THE PT WAS IMPLANTED WITH AN AMS SPECTRA CONCEALABLE PENILE PROSTHESIS. THE DEVICE WAS REMOVED AND REPLACED WITH AN AMS AMBICOR PENILE PROSTHESIS DUE TO EROSION AT "GLANDS". ADD'L INFO WAS REQUESTED, BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS PENILE PROSTHESIS FAE AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R