BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 2090057 · Received May 4, 2011

    Report

    Report Number
    2183959-2011-00153
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    January 14, 2011
    Report Date
    April 28, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT HAD A SPECTRA PENILE PROSTHESIS IMPLANTED. ON (B)(6) 2011, THE DEVICE WAS REPLACED DUE TO INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R