BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLU-U (BLUE LIGHT PHOTODYNAMIC THERAPY III)

    MDR report key: 9676616 · Received February 5, 2020

    Report

    Report Number
    MW5092783
    Event Type
    Injury
    Date Received
    February 5, 2020
    Date of Event
    January 21, 2020
    Report Date
    February 3, 2020
    Manufacturer
    DUSA PHARMACEUTICALS, INC.
    Product Code
    MVF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER LEVULAN KERASTICK AND BLU U TREATMENT FOR ACTINIC KERATOSES, MY FACE WAS SEVERELY BURNED, BLISTERED, BLEEDING, AND SWOLLEN SO BADLY THAT I COULD BARELY OPEN MY EYES. THE BURNING PAIN AND CONSTANT STINGING WAS A 10 ON A PAIN SCALE FROM 1-10 BEING SEVERE. AFTER ICING FOR A FEW DAYS TO RELIEVE THE PAIN, I WAS FINALLY ABLE TO TOUCH MY SKIN IN ORDER TO APPLY THE OINTMENTS TO HELP THE HEALING. THE PHYSICIAN INDICATED THAT I HAD A SEVERE REACTION TO THE MEDICATION AND TREATMENT. THE MFR OF THE MEDICATION AND BLU-U NEED TO TAKE INTO CONSIDERATION IF A PRETEST CAN BE MADE TO DETERMINE WHO WOULD BENEFIT AND WHO WOULD HAVE A SEVERE REACTION LIKE ME. THE BROCHURE DOES NOT BEGIN TO STATE THE SERIOUS SIDE EFFECTS THAT CAN OCCUR. IN ADDITION, THE PHYSICIAN NEEDS TO OFFER A POST TREATMENT PLAN TO ALLEVIATE THE BURNING, STINGING, BLISTERING PAIN. I WAS OFFERED NOTHING UNTIL A WEEK LATER EVEN THOUGH I CALLED EARLIER AND I WAS GIVEN STEROID OINTMENT WHICH HASTENED HEALING. IN ADDITION, THE TREATMENT ACTIVATED MY SHINGLES. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132893 BLU-U (BLUE LIGHT PHOTODYNAMIC THERAPY III) SYSTEM, LASER, PHOTODYNAMIC THERAPY MVF DUSA PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention