BEUDAMED
    FDA Adverse Event Other Summary report: N

    UV LIGHT

    MDR report key: 3360439 · Received September 18, 2013

    Report

    Report Number
    MW5031903
    Event Type
    Other
    Date Received
    September 18, 2013
    Date of Event
    July 23, 2013
    Report Date
    September 18, 2013
    Product Code
    MXG
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER HAS SCLERODERMA DISEASE ( A DISEASE IN WHICH THE SKIN BECOMES PROGRESSIVELY HARD AND THICKENED). SHE MET WITH ONE DR (B)(6), WHO RECOMMENDS A NARROW BAND UV LIGHT THERAPY. DURING TREATMENT SHE WAS EXPOSED TO THE UV LIGHT, SHE NOW HAS BURNS ALL OVER HER BODY, SHE BELIEVE IS SHE STAYED UNDER THE LIGHT LONGER THAN SHE WAS SUPPOSED TO. AFTER FIVE SESSIONS OF THE TREATMENT SHE DEVELOPED SEVERE CONTRACTURE ON SKIN, UPPER AND LOWER ARMS, AND CHEST, ALSO BLISTERS ALL OVER HER ARMS. HER CONDITION GOT WORST THAN SHE WAS BEFORE THE TREATMENT. SHE WAS GIVEN A STEROID OINTMENT (TRIAMCINOLONE) AND PERCOCET FOR PAIN. SHE REFUSES TO GO BACK TO THE DOCTOR AS HE IS NOT HELPING AND SHE DOES NOT KNOW THE MANUFACTURER OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469826 UV LIGHT UV LIGHT MXG

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR