BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 3022765 · Received March 22, 2013

    Report

    Report Number
    2183959-2013-00757
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    September 13, 2012
    Report Date
    February 25, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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 #2183959-2013-00758. IT WAS REPORTED THAT THE PATIENT HAD HIS DEVICE REMOVED BECAUSE THE DEVICE WAS UNCOMFORTABLE. PATIENT WAS IMPLANTED WITH ANOTHER SPECTRA DEVICE FOUR MONTHS LATER ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119091 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS PENILE PROSTHESIS FAE AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R