BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVAIL FX - 72%

    MDR report key: 446814 · Received March 4, 2003

    Report

    Report Number
    MW4003463
    Event Type
    Injury
    Date Received
    March 4, 2003
    Date of Event
    January 16, 2003
    Report Date
    January 29, 2003
    Manufacturer
    APLICARE, INC.
    Product Code
    KXG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS BROUGHT TO OR BY OB NURSE FOR A C-SECTION WHERE PT WAS PREPPED FOR A SPINAL ANESTHETIC. PT WAS THEN PREPPED FOR SURGERY BY WASHING, SHAVING, AND PAINTING WITH AN ALCOHOL-BASED STERILE PREP (PREVAIL FX). A STERILE DRAPE WAS PLACED ON PT. SURGEON BEGAN INCISION WITH THE USE OF CAUTERY. SHORTLY THEREAFTER, PERSONNEL IN THE ROOM HEARD A "POOF" AND SAW FLAMES UNDER THE DRAPE WHICH WERE IMMEDIATELY EXTINGUISHED BY STAFF IN ATTENDANCE. THE C-SECTION PROCEDURE CONTINUED WITH THE DELIVERY AND WITHOUT FURTHER INCIDENT. SHORTLY AFTER DELIVERY IT WAS NOTED THAT THE PT'S RIGHT SIDE WAS PINK AND MEDICAL TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREVAIL FX - 72% PREOPERATIVE PREP SOLUTION KXG APLICARE, INC. 4 VAIL-FX-1.4 OZ. *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention VALLEYLAB FORCE FX ELECTROSURGICAL GENERATOR.