BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1770082 · Received July 9, 2010

    Report

    Report Number
    1770082
    Event Type
    Malfunction
    Date Received
    July 9, 2010
    Date of Event
    June 23, 2010
    Report Date
    July 9, 2010
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A CESAREAN SECTION. THE CAUTERY RELEASE BUTTON ON THE BOVIE PEN DID NOT RELEASE AND STAYED IN THE ON POSITION. THE PEN WAS PLACED ON THE DRAPE AND NOT IN THE HOLDER. THERE WAS A SMALL HOLE IN THE DRAPE INTO THE LEG SECURITY BELT. THE BURN HOLE DID NOT GO THROUGH THE BELT. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BOVIE PEN GEI OLSEN MEDICAL * 014885

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR NO OTHER THERAPIES