BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERICAN MEDICAL SYSTEMS, INC.

    MDR report key: 168446 · Received May 22, 1998

    Report

    Report Number
    168446
    Event Type
    Malfunction
    Date Received
    May 22, 1998
    Date of Event
    May 5, 1998
    Report Date
    May 14, 1998
    Manufacturer
    AMERICAN MEDICAL SYS. INC. PFIZER HOSP. PRODUCTS GROUP
    Product Code
    EZY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MALFUNCTIONING URINARY SPHINCTER REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN MEDICAL SYSTEMS, INC. Implant URINARY SPHINTER EZY AMERICAN MEDICAL SYS. INC. PFIZER HOSP. PRODUCTS GROUP UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other