BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 25228 · Received January 18, 1995

    Report

    Report Number
    25228
    Event Type
    Other
    Date Received
    January 18, 1995
    Date of Event
    December 8, 1994
    Report Date
    December 28, 1994
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    FAE
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF PENILE PROSTHESIS DUE TO MALFUNCTION. ACCORDING TO THE MD, IT IS BELIEVED TO BE IMPLANTED AT OTHER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN Implant PENILE PROSTHESIS FAE AMERICAN MEDICAL SYSTEMS UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other