BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI LASER

    MDR report key: 2091546 · Received April 1, 2011

    Report

    Report Number
    2939653-2011-00011
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    July 15, 2009
    Report Date
    April 1, 2011
    Manufacturer
    IRIDEX CORP.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IRIDEX RESPONDED TO THIS INCIDENT (DATES (B)(6), 2009 AND (B)(6), 2010) UPON REQUEST FROM THE FDA.

    Description of Event or Problem · 1

    PT WAS TREATED FOR LASER SKIN RESURFACING DONE ON NECK, FACE, AND FOREHEAD. PT INDICATES HE EXPERIENCED FACIAL SCARRING AND HYPERPIGMENTATION AS A RESULT OF THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI LASER LASER THERAPY UNIT GEX IRIDEX CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1