BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVULAN/ BLUE LIGHT

    MDR report key: 2657389 · Received July 12, 2012

    Report

    Report Number
    MW5026170
    Event Type
    Injury
    Date Received
    July 12, 2012
    Date of Event
    January 16, 2012
    Report Date
    May 6, 2012
    Manufacturer
    DUSA PHARMACEUTICALS, INC
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A (B)(6) FEMALE PT WHO EXPERIENCED APPLICATION SITE STINGING, TINGLING, REDNESS, SWELLING, CRUSTING AND BLISTERS AFTER RECEIVING A LEVULAN + BLU-U TREATMENT FOR FACIAL ACTINIC KERASTOSES. THE REPORTER STATED - SHE RECOVERED FORM THE EVENTS, BUT THEN (B)(6) WEEKS POST TREATMENT SHE COMPLAINT OF AREAS OF INCREASED REDNESS ON HER FACE PLUS WRINKLES/GROOVES IN HER SKIN WHICH WERE NO PRESENT BEFORE. PRE-TREATMENT/SKIN PREP: RINSED FACE WITH H20. LEVULAN INCUBATION TIME: 30 MINS. BLU-U SETTINGS LENGTH OF ILLUMINATION: 15 MIN AND SECS. DATE OF ONSET OF ADVERSE EXPERIENCE: (B)(6) 2012. I HAD ALL OF THE ABOVE AS STATED WITH A BACTERIAL INFECTION ABOVE MY LIP AND WENT ON ANTIBIOTICS. THESE WERE REALLY SEVERE BURNS. OBVIOUSLY, I HAD A BAD REACTION TO THE LEVALON. IT HAS BEEN (B)(6) MONTHS SINCE HAD THIS TX AND STILL HAVE DISCOLORATION AND REDNESS. IT GETS WORSE WHEN APPLYING MOISTURIZER AND ESPECIALLY WHEN I WORK OUT AND GET FLUSH IN THE FACE. IT GETS REALLY PRONOUNCED AND PATCHY. I AM NOT HAPPY WITH THESE RESULTS OBVIOUSLY AND NOT LIKING THE TEXTURE OF MY SKIN WHICH I FIND CAUSED MORE DAMAGE TO MY SKIN IN THOSE PARTICULAR AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVULAN/ BLUE LIGHT LIGHT THERAPY GEX DUSA PHARMACEUTICALS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other