BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AHMED GLAUCOMA VALVE

    MDR report key: 7136213 · Received December 20, 2017

    Report

    Report Number
    1000125279-2017-00024
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    November 8, 2017
    Report Date
    December 13, 2017
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    KYF
    UDI-DI
    00892064002119
    PMA / PMN Number
    K162060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT REPORTED WAS REVIEWED AND NO ISSUES WERE OBSERVED. THE PRODUCT WAS MANUFACTURED, INSPECTED AND RELEASED IN COMPLIANCE WITH MANUFACTURING PROCEDURES. THE VALVE EXPLANTED HAS NOT BEEN RECEIVED FOR EVALUATION AND WE ARE UNABLE TO DETERMINE THE CAUSE OF THE ISSUE REPORTED.

    Description of Event or Problem · 1

    THE PATIENT IOP WAS 26-30. HER IMPLANT WAS PLACED ON (B)(6) 2017. HER IOP ROSE TO 38. THERE WAS NOTHING UNUSUAL THAT HAPPENED DURING SURGERY. ON (B)(6) 2017 THE PATIENT WAS TAKEN BACK TO SURGERY TO EXPLORATION AND REFORMATION. THERE ARE NO VIDEOS, THE PATIENT WAS SEEN AGAIN ON (B)(6) 2017 - DISCUSSED REMOVING THE AHMED TO MINIMIZE VISION LOSS. HER VISION WAS 20/400. HER IOP WAS 36. ON (B)(6) 2017 HER AHMED WAS REMOVED AND A FRESH TUTOPLAST GRAFT WAS PLACED. SHE WAS SEEN POST OP ON (B)(6) 2017 AND HER IOP POST REMOVAL IS 38

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912749 AHMED GLAUCOMA VALVE GLAUCOMA SHUNT KYF NEW WORLD MEDICAL, INC. FP7 G1017 00892064002119

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention