BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AHMED GLAUCOMA VALVE

    MDR report key: 20623597 · Received November 6, 2024

    Report

    Report Number
    1000125279-2024-00038
    Event Type
    Injury
    Date Received
    November 6, 2024
    Date of Event
    August 1, 2024
    Report Date
    November 4, 2024
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    KYF
    UDI-DI
    00892064002119
    PMA / PMN Number
    K230975
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT WAS REVIEWED AND NO ISSUES WERE OBSERVED. PRODUCT WAS MANUFACTURED, TESTED, AND RELEASED PER VALIDATED PROCEDURES. DEVICE WAS REQUESTED BUT NOT YET RETURNED. IF DEVICE IS RETURNED TO NWM, AN ADDENDUM WILL BE FILED TO CAPTURE EVALUATION.

    Description of Event or Problem · 0

    FLUID PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1860162 AHMED GLAUCOMA VALVE GLAUCOMA DRAINAGE DEVICE KYF NEW WORLD MEDICAL, INC. FP7 M0423 00892064002119

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention