BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPEN

    MDR report key: 207359 · Received January 21, 1999

    Report

    Report Number
    1720159-1998-00081
    Event Type
    Injury
    Date Received
    January 21, 1999
    Date of Event
    December 18, 1998
    Report Date
    December 28, 1998
    Manufacturer
    ASPEN LABORATORIES, INC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS WAS A CRANIOTOMY PROCEDURE. A FIRE BROKE OUT SOMEWHERE AROUND A BAG MADE OF NONWOVEN FABRIC, A METAL SUCTION AND AN ELECTROSURGICAL PENCIL ATTACHED TO A NONWOVEN FABRIC SHEET USED TO COVER THE PT. AFTER 20 MINUTES OF SKIN SECTION, THE DR FELT HEAT AROUND THE PT'S SHOULDER AND FOUND A FIRE AT THE BAG. HE IMMEDIATELY POURED WATER OVER THE AREA, BUT FAILED TO PUT IT OUT. THEN UPON UNCOVERING THE NONWOVEN SHEET, A FLARE CAME UP AND HAD TO BE PUT OUT BY AN EXTINGUISHER. THE PT SUFFERED A LEVEL 3 BURN TO HIS FACE, SEVERER THAN A BLISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPEN ELECTROSURGICAL UNIT GEI ASPEN LABORATORIES, INC. EXCALIBUR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other 1. ELECTROSURGICAL PENCIL,| REFER TO 1720159-1998-00082.| 2. CONMED PENCIL, CATALOGUE #130308, LOT # UNK.