BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR

    MDR report key: 3807966 · Received May 9, 2014

    Report

    Report Number
    1226354-2014-00002
    Event Type
    Other
    Date Received
    May 9, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 8, 2014
    Manufacturer
    DUSA PHARMACEUTICALS, INC.
    Product Code
    MVF
    PMA / PMN Number
    P990019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT RECEIVED TREATMENT FOR ACTINIC KERATOSES WITH LEVULAN KERASTICK AND BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR CONSISTING OF A SKIN PREPARATION WITH CERAVE CLEANSER AND WATER, FOLLOWED BY APPLICATION OF LEVULAN KERASTICK TO THE ENTIRE FACE, INCUBATION OF 1 HOUR, FOLLOWED BY 16 MINUTES 40 SECONDS OF EXPOSURE TO BLU-U LIGHT. PATIENT HAS A HISTORY OF MELANOMA AND ACTINIC KERATOSES AND IS ON WELLBUTRIN FOR ANXIETY AND DEPRESSION. TWO DAYS POST TREATMENT THE PATIENT REPORTED TO HER PHYSICIAN THAT SHE HAD BLISTERS, ITCHING AND SKIN TIGHTNESS. THE PHYSICIAN TOLD HER TO APPLY SPECIFIC TOPICALS FOR RELIEF. THE PATIENT REPORTED THE FOLLOWING MONDAY (3 DAYS AFTER LEVULAN/BLU-U TREATMENT (B)(6) 2014) THAT THE BLISTERS HAD RESOLVED, BUT HER SKIN WAS STILL TIGHT TO WHICH THE PHYSICIAN SUGGESTED VASELINE/DOMEBORO SOAKS. THAT NIGHT ((B)(6) 2014) THE PATIENT REPORTED SHE HAD A SEIZURE. EMS WAS CALLED WHO EVALUATED THE PATIENT BUT DID NOT TRANSPORT HER TO THE HOSPITAL. LATER THAN EVENING THE PATIENT REPORTED HAVING ANOTHER SEIZURE/EVENT AND WAS TAKEN TO THE EMERGENCY ROOM. THE PATIENT'S DERMATOLOGIST REPORTED THAT THE EMERGENCY ROOM PHYSICIAN STATED THE WELLBUTRIN CAUSE THE SEIZURE ACTIVITY. IT IS THE OPINION OF THE COMPANY'S CHIEF MEDICAL OFFICER THAT THE WELLBUTRIN CAUSED THE SEIZURE AND THE EVENT WAS NOT RELATED TO THE LEVULAN KERASTICK/BLU-U TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282097 BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR BLU-U MVF DUSA PHARMACEUTICALS, INC. BLU-U 10K NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other