BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALOMAR VECTUS LASER

    MDR report key: 3331110 · Received August 30, 2013

    Report

    Report Number
    1223483-2013-00001
    Event Type
    Injury
    Date Received
    August 30, 2013
    Date of Event
    August 5, 2013
    Report Date
    August 27, 2013
    Manufacturer
    PALOMAR MEDICAL TECHNOLOGIES, INC.
    Product Code
    GEX
    PMA / PMN Number
    120622
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE R.N. DIRECTED THE WOMAN TO KEEP THE AREA MOISTURIZED WITH NORMAL BODY LOTION AND TO KEEP THE AREA OUT OF THE SUN. ADDITIONALLY, IMAGES OF THE AFFECTED AREA WERE ASSESSED BY A PHYSICIAN WHO SUGGESTED SHE "KEEP IT CLEAN AND SLIGHTLY MOIST WITH AQUAPHOR, PROTECT FROM SUN." THE VECTUS LASER IS IN THE PROCESS OF BEING RETURNED TO PALOMAR FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WOMAN BEING TREATED AT THE REPORTING FACILITY EXPERIENCED BUNS AND BLISTERING ON HER RIGHT LEG FROM TREATMENT WITH THE PALOMAR VECTUS LASER, USING THE LARGE SAPPHIRE OPTIC. ON (B)(6), A PALOMAR R.N. SPOKE WITH THE WOMAN AND SHE INDICATED THE "DARK CRUSTED SCAB CAME OFF A FEW DAYS AGO AND THE TISSUE IS HEALED. THE SURROUNDING TISSUE IS DARKER THAN THE CENTER WHICH IS NOW "WHITISH" IN COLOR." NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428788 PALOMAR VECTUS LASER DIODE LASER SYSTEM GEX PALOMAR MEDICAL TECHNOLOGIES, INC. 3520A-0001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other