BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS

    MDR report key: 3827719 · Received May 22, 2014

    Report

    Report Number
    2183959-2014-00171
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 29, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FHW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED: COMMON DEVICE NAME FROM PENILE PROSTHESIS TO DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC. PRODUCT CODE (FDA) FROM FAE TO FHW.

    Additional Manufacturer Narrative · 1

    UPDATED FROM AMS SPECTRA CONCEALABLE PENILE PROSTHESIS TO AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS. ADDITIONAL INFORMATION RECEIVED THAT INDICATES THE COMPLAINT DEVICE WAS A DYNAFLEX PENILE PROSTHESIS AND NOT A SPECTRA. DYNAFLEX QUALIFIES FOR EXEMPTION (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPECTRA PENILE PROSTHESIS WAS REMOVED DUE TO EROSION AT THE CYLINDER LOCATION. A NEW SPECTRA DEVICE WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305952 AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R