BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AHMED GLAUCOMA VALVE

    MDR report key: 16035782 · Received December 22, 2022

    Report

    Report Number
    1000125279-2022-00053
    Event Type
    Injury
    Date Received
    December 22, 2022
    Report Date
    December 19, 2022
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    KYF
    PMA / PMN Number
    K162060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE IFU WAS REVIEWED AND WAS CONFIRMED TO INCLUDE HYPOTONY AS A KNOWN COMPLICATION AND ADVERSE REACTION. THE DEVICE HISTORY RECORD FOR THE LOT INVOLVED WAS REVIEWED AND NO ISSUES WERE OBSERVED. PRODUCT WAS MANUFACTURED, TESTED, AND RELEASED PER VALIDATED PROCEDURES. DEVICE NOT RETURNED. IF DEVICE IS RETURNED TO NWM, AN ADDENDUM WILL BE FILED TO CAPTURE EVALUATION.

    Description of Event or Problem · 0

    DISTRIBUTOR REPORTED, "HYPOTONY, FLAT AC".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612965 AHMED GLAUCOMA VALVE GLAUCOMA DRAINAGE DEVICE KYF NEW WORLD MEDICAL, INC. FP7 C1722

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other