BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERICAN MEDICAL SYSTEMS, INC.

    MDR report key: 65831 · Received January 3, 1997

    Report

    Report Number
    65831
    Event Type
    Injury
    Date Received
    January 3, 1997
    Date of Event
    July 9, 1996
    Report Date
    July 29, 1996
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FAILED PENILE PROSTHESIS. PROSTHESIS REMOVED. SURGEON NOTED THAT THERE WAS A DISRUPTION IN THE TUBING CONNECTING THE RESERVOIR TO THE PUMP AT THE POINT OF THE CONNECTION WHERE THE CONNECTION HAD ERODED THROUGH THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN MEDICAL SYSTEMS, INC. Implant PENILE PROSTHESIS FHW AMERICAN MEDICAL SYSTEMS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention