BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AHMED GLAUCOMA VALVE

    MDR report key: 5022025 · Received August 21, 2015

    Report

    Report Number
    1000125279-2015-00012
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Report Date
    August 21, 2015
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    KYF
    PMA / PMN Number
    K060644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT RETURNED FOR EVALUATION WAS VISUALLY EVALUATED AND NO ISSUES WERE OBSERVED. THE UNIT WAS TESTED UNDER SIMULATED CONDITIONS AND THE UNIT WAS ABLE TO MAINTAIN PRESSURE BETWEEN 5 AND 21MMHG OVER AN HOUR.

    Description of Event or Problem · 1

    IMPLANTED BUT NEXT DAY PATIENT HAD VERY SHALLOW, LOW PRESSURE. DR. DARLINGTON REMOVED IT AND PLACED ANOTHER M4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554298 AHMED GLAUCOMA VALVE GLAUCOMA SHUNT KYF NEW WORLD MEDICAL, INC. M4 B0715

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention