BEUDAMED
    FDA Adverse Event Other Summary report: N

    PREVAIL-FX ONE-STEP PREP SOLUTION

    MDR report key: 476618 · Received August 7, 2003

    Report

    Report Number
    1423507-2003-00096
    Event Type
    Other
    Date Received
    August 7, 2003
    Report Date
    August 6, 2003
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT STATES THAT A PT WAS PREPPED WITH THE PREVAIL-FX PRIOR TO A LAPAROSCPIC PROCEDURE AND IMMEDIATELY DRAPED WITHOUT WAITING THE APPROPRIATE AMOUNT OF TIME FOR THE SOLUTION TO DRY. APPARENTLY THE BOVIE INSTRUMENT IGNITED A PORTION OF THE DRAPE THAT WAS SOAKED WITH WET SOLUTION. THE FIRE WAS QUICKLY EXTINGUISHED AND NO PT INJURIES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other