BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERICAN MEDICAL SYSTEMS, INC.-PFIZER

    MDR report key: 146602 · Received December 19, 1997

    Report

    Report Number
    146602
    Event Type
    Malfunction
    Date Received
    December 19, 1997
    Date of Event
    October 21, 1997
    Report Date
    November 26, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. PFIZER HOSP PRODUCTS GROUP
    Product Code
    EZY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    URINARY SPHINCTER REMOVED FOR CUFF EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN MEDICAL SYSTEMS, INC.-PFIZER Implant * EZY AMERICAN MEDICAL SYSTEMS, INC. PFIZER HOSP PRODUCTS GROUP AMS ST CUFF 4.0CM CE246009

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other