BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AHMED GLAUCOMA VALVE

    MDR report key: 6999893 · Received November 3, 2017

    Report

    Report Number
    1000125279-2017-00021
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    October 25, 2017
    Report Date
    October 25, 2017
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    KYF
    UDI-DI
    00892064002119
    PMA / PMN Number
    K162060
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT REPORTED WAS REVIEWED AND NO ISSUES WERE OBSERVED. THE PRODUCT WAS MANUFACTURED, TESTED AND RELEASED IN COMPLIANCE WITH MANUFACTURING PROCEDURES. ALL UNITS ARE INSPECTED 100% PRIOR TO RELEASE. THE SAMPLE WAS NOT RETURNED FOR EVALUATION AS THE VALVE WAS LEFT IN THE PATIENT'S EYE. WITHOUT A SAMPLE AVAILABLE FOR EVALUATION WE ARE UNABLE TO VERIFY THE CAUSE OF THE ISSUE REPORTED.

    Description of Event or Problem · 1

    PATIENT HAD FLAT ANTERIOR CHAMBER DAY ONE POSTOP WITH IOP MEASURING 10 BUT VARY SOFT INDICATING OVERFILTRATION. TUBE IN GOOD POSITION WITHOUT WOUND LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778406 AHMED GLAUCOMA VALVE GLAUCOMA SHUNT KYF NEW WORLD MEDICAL, INC. FP7 G1017 00892064002119

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention