BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 3792484 · Received May 6, 2014

    Report

    Report Number
    2183959-2014-00148
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FAE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED FOR EVALUATION. ANALYSIS RESULTS INDICATE THE DEVICE OPERATED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SPECTRA NON-INFLATABLE PENILE PROSTHESIS IMPLANTED ON (B)(6) 2014. THE DEVICE WILL BE REMOVED DUE TO INFECTION, REMOVAL DATE NOT PROVIDED. IT IS UNCERTAIN WHICH, IF ANY, COMPONENTS WILL BE REPLACED AT THIS SURGERY. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272378 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS PROSTHESIS, PENILE FAE AMERICAN MEDICAL SYSTEMS (MN) 772033002

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R