BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 2111804 · Received May 26, 2011

    Report

    Report Number
    2183959-2011-00184
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    April 8, 2011
    Report Date
    May 2, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2009, A SPECTRA NON-INFLATABLE PENILE PROSTHESIS WAS IMPLANTED. ON (B)(6) 2011, THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH AN IPP, DUE TO PATIENT DISSATISFACTION, DETAILS WERE NOT PROVIDED. NO PATIENT COMPLICATIONS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R