BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 2896393 · Received December 28, 2012

    Report

    Report Number
    2183959-2012-03446
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    October 26, 2012
    Report Date
    December 3, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    IT WAS REPORTED THAT THE DEVICE WAS REMOVED DUE TO PATIENT DISSATISFACTION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT PROVIDED. IT WAS INDICATED THAT AN AMS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON THE SAME DAY AS THE REMOVAL.

    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 60 YR Hospitalization| R