BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIGUIDE

    MDR report key: 189349 · Received September 25, 1998

    Report

    Report Number
    8022170-1997-90001
    Event Type
    Death
    Date Received
    September 25, 1998
    Date of Event
    September 27, 1997
    Report Date
    March 10, 1998
    Manufacturer
    QLT PHOTOTHERAPEUTICS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TRANSMURAL NECROSIS OF THE ESOPHAGUS LEADING TO MULTIPLE PERFORATIONS AND DEATH. PHOTODYNAMIC THERAPY IS A 2-STEP PROCESS INVOLVING BOTH INJECTION OF A PHOTOSENSITIZER (PHOTOFRIN) AND ILLUMINATION WITH APPROPRIATE LIGHT DELIVERY DEVICES. QLT PHOTOTHERAPEUTICS HOLDS THE NDA FOR PHOTOFRIN (20,451) AND THE PMA FOR THE FIBER OPTIC DIFFUSERS, OPTIGUIDE (PMA-940010). THIS REPORT COVERS BOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIGUIDE FIBER OPTIC DIFFUSER GEX QLT PHOTOTHERAPEUTICS, INC. DCYL25, DCYL10 DCYL25: 10-4173-647, (MORE)

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| H COHERENT PHOTODYNAMIC LASER.