BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRABECTOME® DRAPING SYSTEM

    MDR report key: 8361205 · Received February 22, 2019

    Report

    Report Number
    8361205
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Date of Event
    January 22, 2019
    Report Date
    February 13, 2019
    Manufacturer
    NEOMEDIX CORPORATION
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRIOR TO THE SURGICAL PROCEDURE, WHEN THE SURGEON WENT TO USE IT, STATED HE WAS NOT HAPPY WITH THE WAY THE TIP WAS FORMED. THE SURGEON REFUSED TO USE THE DEVICE AND IT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156939 TRABECTOME® DRAPING SYSTEM DRAPE, SURGICAL KKX NEOMEDIX CORPORATION 600018-04 170726-02

    Patients

    Seq Age Sex Outcome Treatment
    1 22630 DA