BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 3981262 · Received August 5, 2014

    Report

    Report Number
    2183959-2014-00347
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    June 3, 2014
    Report Date
    July 29, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FAE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPECTRA PENILE PROSTHESIS WAS REVISED DUE TO 'PATIENT DISSATISFACTION; GLANS PART PAIN (REDUCING SIZE)'. ANOTHER SPECTRA DEVICE WAS IMPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458172 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS PROSTHESIS, PENILE FAE AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R