BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUX IR

    MDR report key: 902267 · Received August 21, 2007

    Report

    Report Number
    MW5003512
    Event Type
    Injury
    Date Received
    August 21, 2007
    Date of Event
    July 17, 2007
    Report Date
    August 21, 2007
    Manufacturer
    PALOMAR MEDICAL TECHNOLOGIES, INC
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT'S FACE WAS BURNED DURING LASER TREATMENT. PATIENT EXPERIENCED PAIN, EXTREME FACE SWELLING AND CONTACTED PI ON 07/16/07 IN THE MORNINGS AT 12:30 AM. PATIENT COMPLAINED THAT PROCEDURE WAS NOT EXPLAINED TO HER AND THAT SHE DID NOT EXPECT SUCH EFFECT FROM THE PROCEDURE. DATE OF USE: 1 HRS, ONE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUX IR LUX DEEP IR GEX PALOMAR MEDICAL TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other