BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLEX

    MDR report key: 11982476 · Received June 11, 2021

    Report

    Report Number
    11982476
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 3, 2021
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 0

    THE LASER AIMING BEAM (ONE OF THE RED DOTS) OF THE LASEREX ELLEX OPHTHALMIC YAG LASER WAS MISSING.

    Description of Event or Problem · 1

    THE LASER AIMING BEAM (ONE OF THE RED DOTS) OF THE LASEREX ELLEX OPHTHALMIC YAG LASER WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883745 ELLEX LASER, OPHTHALMIC HQF ELLEX MEDICAL PTY LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 26280 DA