BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIGUIDE

    MDR report key: 126291 · Received October 13, 1997

    Report

    Report Number
    126291
    Event Type
    Death
    Date Received
    October 13, 1997
    Date of Event
    September 24, 1997
    Report Date
    October 10, 1997
    Manufacturer
    QLT PHOTOTHERAPEUTICS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHOTODYNAMIC THERAPY FOR CARCINOMA OF ESOPHAGUS. NAUSEA, VOMITING, EPIGASTRIC PAIN 3AM, 9/25- PERSISTED THROUGH 9/27, WHEN PT DEVELOPED SHORTNESS OF BREATH, HYPOTENSION. INTUBATED TRANSFERRED TO ICU. PT CONTINUED TO DETERIORATE- EXPIRED 9/28/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIGUIDE DIFFUSER (FIBEROPTIC) FOR PDT GEX QLT PHOTOTHERAPEUTICS, INC. * 10-4171-704 (1CM X 5M)

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death LASER: COHERENT