BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLU-U

    MDR report key: 10282607 · Received July 15, 2020

    Report

    Report Number
    MW5095541
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    April 6, 2020
    Report Date
    July 13, 2020
    Manufacturer
    DUSA PHARMACEUTICALS, INC.
    Product Code
    MVF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WENT TO DERMATOLOGIST FOR ROSACEA, SHE APPLIED LEVULAN KERASTICK AND BLU-U LIGHT, I WAS NOT GIVEN A PAMPHLET ON THIS OR ANYTHING UNTIL IT WAS COMPLETED OR I WOULD HAVE NEVER AGREED TO THIS AT ALL. AS SOON AS I GOT HOME I WAS BURNING UP AND I STARTED TO HAVE A SEVERE REACTION TO THIS. I TRIED TO DO WHAT I COULD, I WAS HAVING EXTREMELY HOT AND COLD NEEDLES RUNNING UP AND DOWN MY WHOLE BODY FROM MY HEAD TO MY TOES EXTREMELY PAINFUL, AND MY BLOOD PRESSURE DROPPED TO THE POINT I WAS PASSING OUT; I DID THIS FOR ABOUT 6 DAYS AND FINALLY WENT TO EMERGENCY ROOM ON (B)(6) FOR HELP WHERE THEY ADMINISTERED FLUIDS AND DRAMAMINE AND PREDNISONE. WHEN I CALLED THE DR AT DERMATOLOGY, SHE JUST SAID, I AM STILL UNDER MY DOCTORS HELP TO GET THROUGH THIS AND IT HAS BEEN 3 MONTHS OF PURE HELL. NOW I AM HAVING PROBLEMS WITH MY ESOPHAGUS AND STOMACH , HAVE NOW GOT NEUROPATHY IN MY FEET AND BEEN TO THAT I MAY GET IT IN OTHER PARTS OF BODY ALSO TROUBLE WITH URINARY TRACK. I DID NOT HAVE ANY OF THIS BEFORE. I AM STILL ON ANTIHISTAMINE, (B)(6), I CANNOT GO OUTSIDE OR ALL THE BURNING COMES BACK IN MY WHOLE BODY, AND NOT SURE WHAT ELSE I AM GOING TO HAVE SHOW UP AS A RESULT OF THIS PRODUCT. STILL HAVING SEVERE BURNING ALL OVER MY INSIDES THAT LAST FOR HOURS. PRIOR TO THIS I HAD COMPLETED MY ANNUAL EXAMS AND EVERYTHING WAS COMING BACK FINE. THIS HAS BEEN A NIGHTMARE AND I STILL DON'T KNOW WHAT IT DID TO MY OTHER ORGANS. FIRST OF ALL THIS PAMPHLET SHOULD HAVE BEEN GIVEN ME BEFORE SHE PUT THE STUFF ON ME NOT AFTER SHE WAS DONE. I HAD NO IDEA WHAT I WAS GETTING INTO. I AM (B)(6) AND I CERTAINLY WOULD NOT HAVE DONE THIS ON PURPOSE. SHE TOLD ME I HAD TO DO THIS BECAUSE SHE ALREADY HAD THE CREAM ON MY FACE. MY WHOLE LIFE HAS CHANGED, I USED TO DANCE THREE OR FOUR TIMES A WEEK AND NOW WITH THE NEUROPATHY IN MY FEET, I HAVE LOST MY BALANCE, I LOVED TO GARDEN ETC AND SWIM OUT IN MY POOL AND CANNOT GO OUT IN THE SUN ANYMORE OR THE PAINFUL ATTACKS RETURN ALL OVER MY BODY. I WAS IN VERY GOOD HEALTH AND VERY ACTIVE RIGHT UP TO THE DAY THIS HAPPENED, AND NOW I AM A MESS. FOLLOWED UP WITH FAMILY PHYSICIAN, BLOOD TESTS WERE RUN CBC, ETC AND I AM STILL HAVING TEST RUN NOW AS A RESULT; (B)(6) PHARMACEUTICALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738697 BLU-U SYSTEM, LASER, PHOTODYNAMIC THERAPY MVF DUSA PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| S