BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 6002407 · Received October 6, 2016

    Report

    Report Number
    2183959-2016-00170
    Event Type
    Injury
    Date Received
    October 6, 2016
    Report Date
    September 23, 2016
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FAE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SPECTRA PENILE PROSTHESIS REMOVED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE DUE TO UNSPECIFIED REASONS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658592 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS PROSTHESIS, PENILE FAE AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R