BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1860352 · Received September 17, 2010

    Report

    Report Number
    1860352
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 16, 2010
    Manufacturer
    IRIDEX
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    DEVICE FAILED TO FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LASER PROBE HQF IRIDEX 14400-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *