BEUDAMED
    FDA Adverse Event Other Summary report: N

    PREVAIL-FX

    MDR report key: 445142 · Received February 28, 2003

    Report

    Report Number
    445142
    Event Type
    Other
    Date Received
    February 28, 2003
    Date of Event
    December 31, 2002
    Report Date
    January 10, 2003
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP
    Product Code
    KXG
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT SKIN PREPPED WITH PREVAIL FX PRIOR TO INITATION OF TRACHEOTOMY. SURGEONS NOTED EXCESSIVE SMOKE AROUND SURGICAL FIELD WHILE USING ELECTROCAUTERY UNIT. SMALL FLAME NOTICED UNDER SURGICAL DRAPE OVER FACE WHICH WAS IMMEDIATELY EXTINGUISHED. PT SUSTAINED 2ND AND 3RD DEGREE BURNS TO RIGHT SIDE OF FACE, EAR LOBE AND RIGHT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREVAIL-FX TOPICAL PREOPERATIVE PREP SOLUTION WITH APPLICATOR KXG ALLEGIANCE HEALTHCARE CORP * 84441

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other