BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATOR

    MDR report key: 7397066 · Received April 4, 2018

    Report

    Report Number
    1226354-2018-00009
    Event Type
    Injury
    Date Received
    April 4, 2018
    Report Date
    April 4, 2018
    Manufacturer
    DUSA PHARMACEUTICALS, LNC.
    Product Code
    MVF
    PMA / PMN Number
    P99001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT REPORTED TO HER DOCTOR'S OFFICE THAT SHE HAS CORNEAL BURNS ON HER EYES FROM HAVING PDT DONE. FOLLOW-UP ((B)(6) 2018; (B)(6) 2018): PATIENT REPORTED TO THE DOCTOR'S OFFICE SHE WENT TO THE EYE DOCTOR AND CAME BACK WITH CORNEAL BURNS.

    Description of Event or Problem · 1

    CORNEAL BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238853 BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATOR BLU-U MVF DUSA PHARMACEUTICALS, LNC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other