BEUDAMED
    FDA Adverse Event Other Summary report: N

    N-LITE

    MDR report key: 452729 · Received April 6, 2003

    Report

    Report Number
    MW1028086
    Event Type
    Other
    Date Received
    April 6, 2003
    Date of Event
    November 19, 2002
    Report Date
    April 6, 2003
    Manufacturer
    ICN PHOTONICS
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THREE DAYS FOLLOWING FIRST TREATMENT OF N-LITE TO REDUCE WRINKLES, PT EXPERIENCED LOWER EYELID EDEMA/SEROMA FORMATION. THE N-LITE WAS SET AT 2.8J AND THE AREA WAS TREATED WITHOUT ANY OVERLAP OF PULSES. SEROMAS WERE 4.5 CM IN DIAMETER AND CONSISTED OF NONTENDER DIFFUSE FLUID FILLED AREAS. EDEMA CONTINUED UNTIL MARCH 2003, AT WHICH TIME IT RESOLVED SPONTANEOUSLY. MICRODERMABRASION PRECEEDING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N-LITE PULSE DYE LASER GEX ICN PHOTONICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other