BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 2801008 · Received October 18, 2012

    Report

    Report Number
    2183959-2012-02893
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    August 27, 2012
    Report Date
    September 26, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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

    IT WAS INDICATED THAT THE DEVICE WAS REMOVED AND REPLACED WITH AN AMS AMBICOR PENILE PROSTHESIS DUE TO PT DISSATISFACTION, THE PRODUCT BENT UNDER SLIGHT PRESSURE, COULD NOT MAINTAIN AN ERECTION.

    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 68 YR Hospitalization| R