BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLU-U

    MDR report key: 21378671 · Received February 13, 2025

    Report

    Report Number
    MW5166158
    Event Type
    Injury
    Date Received
    February 13, 2025
    Date of Event
    February 6, 2025
    Report Date
    February 7, 2025
    Manufacturer
    SUN PHARMACEUTICAL INDUSTRIES, INC.
    Product Code
    MVF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD A BLUE LIGHT PHOTODYNAMIC THERAPY AT DERMATOLOGIST OFFICE. MY FACE WAS WIPED WITH ACETONE ON MULTIPLE SPOTS THEN LEVULAN KERASTICK APPLIED OVER THOSE SAME AREAS. I FELT A DRIP HEADING FOR MY EYES AND WAS GIVEN A PAPER TOWEL TO WIPE NEAR EYES. I THEN WAS GIVEN A HAT AND SENT OUT INTO A WAITING AREA FOR 1 HOUR 20 MINUTES. I THEN WAS BROUGHT INTO A ROOM WHERE THE LIGHT WAS LOCATED ON A STAND. I WAS FITTED WITH SMALL GOGGLES OVER MY EYES THEN TOLD I WOULD FEEL HOT SENSATIONS AND WAS GIVEN A HAND HELD FAN. THE LIGHT WAS POSITIONED VERY CLOSE, I COULDN'T SEE, THEN TURNED ON WHILE THE 2 ATTENDANTS LEFT THE ROOM AND CLOSED THE DOOR. IT DIDN'T TAKE LONG FOR THE BURNING FEELING ON MY FACE TO BECOME INTENSE AND INTOLERABLE. I SCREAMED OUT CALLING FOR HELP AND FINALLY HAD TO KICK THE ROLLING LIGHT STAND AWAY FROM ME. IT WAS TRAUMATIC. I OPENED THE DOOR WHILE THE ATTENDANTS AND NP CAME TO THE ROOM AS THEY THOUGHT THAT THEY HAD HEARD ME. I THINK THAT THE PROCEDURE SHOULD HAVE BEEN OBSERVED BY A TRAINED PROFESSIONAL THE ENTIRE TIME. FORTUNATELY I WAS NOT HURT KICKING AN EXTREMELY HOT LAMP AWAY FROM MY BODY. NOW FOR 40 HOURS FOLLOWING I STILL HAVE TO AVOID SUNLIGHT AND ARTIFICIAL LIGHTING AS NO ONE KNOWS WHAT THE EFFECT OF THE LEVULAN KERASTICK MIGHT DO TO MY FACE. I JUST HOPE THAT THERE WON'T BE ANY LONG LASTING PROBLEMS WITH LIGHT ON MY FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126725 BLU-U SYSTEM, LASER, PHOTODYNAMIC THERAPY MVF SUN PHARMACEUTICAL INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other CALCIUM PROBIOTICS.| TYLENOL.| VALACYCLOVIR.