BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIOMED

    MDR report key: 343940 · Received July 26, 2001

    Report

    Report Number
    343940
    Event Type
    Injury
    Date Received
    July 26, 2001
    Date of Event
    June 12, 2001
    Report Date
    June 22, 2001
    Manufacturer
    DIOMED INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT INCURRED AIRWAY FIRE INJURY DURING PHOTODYNAMIC THERAPY. APPROX 3 MINUTES INTO THE PDT TREATMENT THE PDT FIBER APPEARED TO MELT. THE FIBER WAS IMMEDIATELY REMOVED AND IN DOING SO, AN AIRWAY FIRE WAS NOTED. THE FIRE WAS IMMEDIATELY EXTINGUISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33620 DIOMED LASER GEX DIOMED INC. T2USA *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R OPTIGUIDE FIBER OPTIC FOR PDT.