BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 6185411 · Received December 19, 2016

    Report

    Report Number
    2183959-2016-00194
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    May 25, 2016
    Report Date
    December 12, 2016
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FAE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD HIS SPECTRA PENILE PROSTHESIS REMOVED DUE TO INFECTION. THE PATIENT HAD AN INFLATABLE PENILE PROSTHESIS IMPLANTED ON (B)(6) 2016. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836802 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS PROSTHESIS, PENILE FAE AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R