BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 2780519 · Received October 5, 2012

    Report

    Report Number
    2183959-2012-02851
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    July 22, 2011
    Report Date
    September 21, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    RELATED TO MFR REPORT # 2183959-2012-02716. IT WAS INDICATED THAT THE RIGHT CYLINDER WAS REMOVED DUE TO INFECTION AND EROSION AT "GLANS".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R