BEUDAMED
    FDA Adverse Event Other Summary report: N

    PREVAIL-FX ONE-STEP PREP SOLUTION

    MDR report key: 415664 · Received September 9, 2002

    Report

    Report Number
    1423507-2002-00117
    Event Type
    Other
    Date Received
    September 9, 2002
    Date of Event
    August 8, 2002
    Report Date
    September 9, 2002
    Manufacturer
    ALLEGIANCE HEALTHCARE CORPORATION
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THEY WERE USING THE 4VAIL-FX FOR PATIENT PREP AND THEN WENT TO USE A CATUERY PENCIL IN THE OR. THE STAFF HEARD A SWOOSHING SOUND AND SMELLED SOMETHING BURNING. THE NURSE MANAGER IN THE OR STATED THAT THE 4VAIL-FX WAS NOT COMPLETELY DRY AS STATED IN THE INSTRUCTIONS AND THAT IS WHY THE REACTION TOOK PLACE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREVAIL-FX ONE-STEP PREP SOLUTION PATIENT PREPPING KXG ALLEGIANCE HEALTHCARE CORPORATION 4VAIL-FX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other