BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR

    MDR report key: 620327 · Received July 6, 2005

    Report

    Report Number
    1226354-2005-00052
    Event Type
    Other
    Date Received
    July 6, 2005
    Date of Event
    May 10, 2005
    Report Date
    June 24, 2005
    Manufacturer
    DUSA PHARMACEUTICALS, INC.
    Product Code
    MVF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS TREATED FOR A HAND WART IN 2005. THE LEVULAN KERASTICK WAS APPLIED TO THE WART FOR 30 MINUTES FOLLOWED BY APPROXIMATELY 8 MINUTES BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR LIGHT. THE PATIENT WORE GOGGLES DURING THE TREATMENT. THE PATIENT WENT HOME AND EXPERIENCED A SEIZURE LATER THAT EVENING. AS REPORTED BY THE PHYSICIAN'S OFFICE THE PATIENT HAS EXPERIENCED AT LEAST ONE SEIZURE PREVIOUSLY (FOLLOWING A DENTAL PROCEDURE). PATIENT WENT TO THE HOSPITAL AFTER THE SEIZURE BUT IT IS UNKNOWN IF THEY WERE ADMITTED. PHYSICIAN'S OFFICE STATED THE FOLLOWING MONTH THAT THEY BELIEVE THE PATIENT IS RECOVERED.

    Description of Event or Problem · 1

    A PT TREATED FOR A HAND WART IN 05. THE LEVULAN KERASTICK WAS APPLIED TO THE WART FOLLOWED 30 MINUTES LATER BY APPROX 8 MINUTES OF LIGHT BY THE BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR. THE PT WORE GOGGLES DURING THE TREATMENT. THE PT WENT HOME AND EXPERIENCED A SEIZURE LATER THAT EVENING. THE PT HAS EXPERIENCED AT LEAST ONE SEIZURE PREVIOUSLY (FOLLOWING A DENTAL PROCEDURE). PT WENT TO THE HOSPITAL AFTER THE SEIZURE BUT IT IS UNKNOWN IF THEY WAS ADMITTED. THE PT WAS NOT ADMITTED TO THE HOSPITAL FOLLOWING THE SEIZURE OF 05. THE PT HAS A HISTORY OF SEIZURES (AT LEAST ONE PREVIOUSLY), BUT HAD BEEN SEIZURE FREE FOR 1 YEAR PRIOR TO CURRENT EPISODE. PT IS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR LIGHT, PHOTODYNAMIC MVF DUSA PHARMACEUTICALS, INC. 4170 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Life Threatening| O