BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALOMAR MAX G

    MDR report key: 2428379 · Received January 19, 2012

    Report

    Report Number
    MW5023937
    Event Type
    Other
    Date Received
    January 19, 2012
    Date of Event
    September 22, 2011
    Report Date
    January 19, 2012
    Manufacturer
    PALOMAR MEDICAL TECHNOLOGIES, INC.
    Product Code
    ILY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED ONE IPL TREATMENT ON A PALOMAR MAX G MACHINE. SETTINGS: 32J, 20MS, ONE PASS TO FACE. ADVERSE REACTION RESULTING IN INFLAMMATION FOR MONTHS, FLUSHING, BURNING SENSATION TO FACE, HYPER-SENSITIVITY. ENLARGED PORES, PIN-PRICK MARKS, MICRO-SCARRING WITH SMALL LINES, INDENTS, AND LOSS OF FACIAL VOLUME. DOCTOR WHO PERFORMED THIS TREATMENTS WILL NOT RESPOND TO PHONE CALLS, EMAILS, OR CERTIFIED LETTERS TO HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALOMAR MAX G PALOMAR MAX G ILY PALOMAR MEDICAL TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other PALOMAR MAX G WAS USED ON ME.