BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AHMED GLAUCOMA VALVE

    MDR report key: 9862673 · Received March 20, 2020

    Report

    Report Number
    1000125279-2020-00011
    Event Type
    Injury
    Date Received
    March 20, 2020
    Report Date
    February 28, 2020
    Manufacturer
    NEW WORLD MEDICAL, INC
    Product Code
    KYF
    UDI-DI
    00892064002119
    PMA / PMN Number
    K162060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR RETURNED AN EXPLANTED VALVE TO NEW WORLD MEDICAL. NWM HAS CONTACTED CUSTOMER TO OBTAIN FURTHER INFORMATION EVALUATION OF SAMPLE RETURNED IS PENDING RECEIPT OF INFORMATION FROM DR.

    Description of Event or Problem · 1

    CUSTOMER RETURNED EXPLANTED VALVE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323875 AHMED GLAUCOMA VALVE GLAUCOMA SHUNT KYF NEW WORLD MEDICAL, INC FP7 NOT PROVIDED 00892064002119

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention