BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 2854183 · Received November 29, 2012

    Report

    Report Number
    2183959-2012-03049
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS: THERE WERE HOLES IN THE OUTER LAYER THAT APPEARED TO BE OPERATING ROOM DAMAGE AND THE RESULT OF A SHARP INSTRUMENT, THE HOLES EXPOSED THE INNER COMPONENTS. THE CYLINDERS FUNCTIONED AS INTENDED. 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 A SPECTRA CONCEALABLE PENILE PROSTHESIS WAS REMOVED DUE TO PT DISSATISFACTION; THE PT WANTED AN INFLATABLE DEVICE. NO PT COMPLICATIONS WERE REPORTED.

    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 66 YR Hospitalization