BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS 800

    MDR report key: 5409702 · Received February 4, 2016

    Report

    Report Number
    5409702
    Event Type
    Malfunction
    Date Received
    February 4, 2016
    Date of Event
    October 9, 2014
    Report Date
    November 16, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, LLC
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PREOPERATIVE DIAGNOSIS: URINARY INCONTINENCE. PROCEDURE: REPLACEMENT OF RESERVOIR FOR ARTIFICIAL URINARY SPHINCTER. POSTOPERATIVE DIAGNOSIS: SAME, LEAK IN RESERVOIR PUMP TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67132 AMS 800 DEVICE, INCONTINENCE, MECHANICAL/HYDRAULIC EZY AMERICAN MEDICAL SYSTEMS, LLC N/A 861997001

    Patients

    Seq Age Sex Outcome Treatment
    1