BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRAXEL RESTORE LASER

    MDR report key: 3040076 · Received April 1, 2013

    Report

    Report Number
    MW5029621
    Event Type
    Injury
    Date Received
    April 1, 2013
    Date of Event
    July 31, 2012
    Report Date
    April 1, 2013
    Manufacturer
    SOLTA/RADIANT TECHNOLOGIES
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FRAXEL RESTORE LASER DAMAGE TO FACE. DEVICE MADE BY SOLTA/RADIANT TECHNOLOGIES. POTENTIAL SIDE EFFECTS NOT IN COMPANY LITERATURE, RISKS NOT COMMUNICATED. PIN DOT MARKS/SCARRING OCCURRED. POSSIBLE ATROPHIC INJURY. DOSE: 30 MJ, LEVEL 5,8 PASSES. REASON FOR USE: IMPROVE SKIN TEXTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132666 FRAXEL RESTORE LASER FRAXEL RESTORE GEX SOLTA/RADIANT TECHNOLOGIES * NO IDEA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability