BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVAIL-FX ONE-STEP PREP SOLUTION

    MDR report key: 508037 · Received January 26, 2004

    Report

    Report Number
    1423507-2004-00008
    Event Type
    Injury
    Date Received
    January 26, 2004
    Date of Event
    December 10, 2003
    Report Date
    January 26, 2004
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KXG
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ACCOUNT STATES THAT "PT PREPPED AND DRAPED IN NORMAL FASHION. INCISION MADE, CAUTERIZATION BEGAN. UPON SECOND PASS OF CAUTERY, A LOUD EXPLOSIVE SOUND WAS MADE WITH FLAMER IMMEDIATELY SECONDS LATER. FLAMER QUICKLY EXTINGUISHED BY SMOTHERING AND USE OF SALINE. BURNS NOTED ON PT AS A RESULT. SURGICAL PREP SOLUTION IS THOUGHT (BY CUSTOMER) TO BE A FACTOR IN THIS INCIDENT. REPORTS ARE BEING FILED WITH THE "ESU" AND SURGICAL PREP MANUFACTURERS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREVAIL-FX ONE-STEP PREP SOLUTION PATIENT PREP KXG CARDINAL HEALTH 4VAIL-FX POSSIBLY Y3K0379

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR