BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOD GLAUCOMA VALVE WITH LOW PROFILE DISK

    MDR report key: 160598 · Received April 2, 1998

    Report

    Report Number
    1220850-1998-00001
    Event Type
    Malfunction
    Date Received
    April 2, 1998
    Date of Event
    March 4, 1998
    Report Date
    April 2, 1998
    Manufacturer
    E. BENSON HOOD LAB, INC.
    Product Code
    KYF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE FOR IMPLANTING THE EY-6005 WAS NOT FOLLOWED COMPLETELY. THE HOOD INTENDED USE AND INSTRUCTIONS MANUAL DETAILS A VALVE MANIPULATION PROCEDURE THAT CAUSES AND CONFIRMS PROPER FUNCTIONING OF THE DEVICE. THE DEVICE WAS IMPLANTED WITHOUT THE VALVE MANIPULATION PROCEDURE BEING FOLLOWED. THE PHYSICIAN CONFIRMED THAT SHE DID NOT FOLLOW THE RECOMMENDED PROCEDURE AND THAT SHE DID NOT PREPARE THE DEVICE CORRECTLY IN ORDER TO ACTIVATE THE VALVE. AFTER IMPLANTATION THE VALVE CONTINUED NOT TO OPERATE PROPERLY AND HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOOD GLAUCOMA VALVE WITH LOW PROFILE DISK Implant HOOD GLAUCOMA VALVE KYF E. BENSON HOOD LAB, INC. EY-6005 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention