BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AHMED GLAUCOMA VALVE

    MDR report key: 6151009 · Received December 7, 2016

    Report

    Report Number
    1000125279-2016-00019
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Manufacturer
    NEW WORLD MEDICAL, INC
    Product Code
    KYF
    PMA / PMN Number
    K162060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED CUSTOMER TO OBTAIN FURTHER INFORMATION; NO INFORMATION HAS BEEN PROVIDED. WE HAVE REVIEWED OUR CURRENT MANUFACTURING PROCESSES AND NO ISSUES WERE OBSERVED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE OBSERVED. NO PRODUCT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    DR. (B)(6) HAD 4 RECENT EXPLANTS DUE TO LOW IOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803395 AHMED GLAUCOMA VALVE GLAUCOMA SHUNT KYF NEW WORLD MEDICAL, INC FP7 D0516

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention