BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 CONTROL PUMP W/IZP

    MDR report key: 1354976 · Received March 25, 2009

    Report

    Report Number
    1354976
    Event Type
    Injury
    Date Received
    March 25, 2009
    Date of Event
    March 5, 2009
    Report Date
    March 16, 2009
    Manufacturer
    AMERICAN MEDICAL SOLUTIONS
    Product Code
    EZY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED TO HOSPITAL IN 2009 WITH PREOPERATIVE DIAGNOSIS OF "MALFUNCTIONING AMS ARTIFICIAL URINARY SPHINCTER". PROCEDURE PERFORMED WAS "REMOVAL AND REPLACEMENT OF AN AMS ARTIFICIAL URINARY SPHINCTER WITH PLACEMENT OF A DOUBLE CUFF". PER THE MEDICAL RECORD, IT APPEARS THESE DEVICES WERE IMPLANTED IN 2008: INFORMATION ON 2ND: 4 0 CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS 800 CONTROL PUMP W/IZP AMS 800 EZY AMERICAN MEDICAL SOLUTIONS 554259009
    2 AMS ST CUFF W/ IZ AMS 800 EZY AMERICAN MEDICAL SOLUTIONS 554821015

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization