BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 3871107 · Received June 13, 2014

    Report

    Report Number
    2183959-2014-00213
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FAE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT HIS SPECTRA MALLEABLE DEVICE WILL BE REMOVED DUE TO URETHRAL EROSION, PAIN, BLEEDING, CURVATURE OF PENIS AND "DEVICE DIDN'T BEND PROPERLY FROM THE BEGINNING". NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350940 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS PROSTHESIS, PENILE FAE AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention| S