BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICARE

    MDR report key: 146696 · Received January 29, 1998

    Report

    Report Number
    146696
    Event Type
    Malfunction
    Date Received
    January 29, 1998
    Date of Event
    August 11, 1997
    Report Date
    August 26, 1997
    Manufacturer
    AMERICAN WHITE CROSS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WHO WAS ORALLY INTUBATED, UNDERWENT THE EXCISION OF A SUBLINGUAL CYST. A SURGICARE HITEMP-FINE TIP CAUTERY WAS PASSED OVER THE SURGICAL FIELD WITH THE HEATING ELEMENT ON IN PREPARATION OF CAUTERIZING THE TONGUE, WHEN SEVERAL FLAMES WERE NOTICED ON THE BAXTER HALF SHEET WHICH WAS DRAPING THE PT'S LEGS. THE FLAMES WERE IMMEDIATELY EXTINGUISHED BY THE SURGEON BY PATTING THEM OUT WITH HER HANDS. THE PT WAS SUBSEQUENTLY FOUND TO HAVE A BLISTER ON HER CHIN THAT WAS TREATED WITH SILVADENE CREME. NO BURNS WERE PRESENT ON HER LEGS HOWEVER, THE BLANKET UNDER THE BAXTER SHEET WAS SINGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICARE CAUTERY HITEMP-FIINE TIP STERILE DISPOSABLE GEI AMERICAN WHITE CROSS 22669 *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Other 1. BAXTER HALF SHEET| 2. BETADINE PREP ON FACE| 3. INFANT WARMER