BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLU-U PHOTODYNAMIC ILLUMINATOR

    MDR report key: 382988 · Received March 6, 2002

    Report

    Report Number
    1226354-2002-00001
    Event Type
    Other
    Date Received
    March 6, 2002
    Date of Event
    January 24, 2002
    Report Date
    March 5, 2002
    Manufacturer
    DUSA PHARMACEUTICALS, INC.
    Product Code
    MVF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A HEALTHCARE PRACTITIONER(PHYSICIANS ASSISTANT)WITH A HISTORY OF EPILEPSY,EXPERIENCED A PETIT MAL EPILETIC SEIZURE 30 MINUTES AFTER ADMINISTRATION OF THE BLU-U LIGHT TREATMENT ON A PATIENT. THE PATIENT (ADMINISTERING HEALTHCARE PROFESSIONAL)SAW THEIR PHYSICIAN THE FOLLOWING DAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other