BEUDAMED
    FDA Adverse Event Other Summary report: N

    N-LITE LASER

    MDR report key: 452715 · Received April 6, 2003

    Report

    Report Number
    MW1028085
    Event Type
    Other
    Date Received
    April 6, 2003
    Date of Event
    February 25, 2003
    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

    PT RECEIVED N-LITE LASER TREATMENTS TO REDUCE WRINKLES IN 10/02, 11/02, AND 2003. LASER WAS SET AT 2.6J, 3.0J, AND 3.2 J FOR EACH TREATMENT, RESPECTIVELY. FOLLOWING EACH TREATMENT, PT FELT THE LASER DID NOT MAKE ANY DIFFERENCE IN THEIR APPEARANCE. PT DEMANDED REFUND OF $2,000 IN 2003. MICRODERMABRASION PRIOR TO FIRST TWO TREATMENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other