BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIDEX

    MDR report key: 1202125 · Received October 12, 2008

    Report

    Report Number
    MW5008621
    Event Type
    Malfunction
    Date Received
    October 12, 2008
    Date of Event
    August 22, 2008
    Report Date
    October 12, 2008
    Manufacturer
    IRIDEX
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN SURGEON REQUESTED LASER PROBE, HE INDICATED THAT THE ILLUMINATION WAS NOT WORKING AND REQUESTED A NEW PROBE WHICH DID WORK. EACH TIME PROBES NEED TO BE SWITCHED. BIOMED WAS CONTACTED REGARDING LASER. PT WITH VITREOUS HEMORRHAGE REPAIR, NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRIDEX IRIDEX DIODE LASER GEX IRIDEX 8050413

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other