BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLSEN

    MDR report key: 1315477 · Received February 9, 2009

    Report

    Report Number
    1315477
    Event Type
    Malfunction
    Date Received
    February 9, 2009
    Date of Event
    January 23, 2009
    Report Date
    February 9, 2009
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A PARTIAL GLOSSECTOMY A SUPERFICIAL BURN WAS NOTED JUST RIGHT OF MIDLINE OF THE PATIENT'S LOWER LIP AND CORRESPONDING TO THE EDGE OF THE BOVIE EXTENDER. EXTENDER WAS IMMEDIATELY REMOVED. THE INSIDE RIM OF THE EXTENDER, ABOUT 1/4 INCH IN, WAS NOTED TO HAVE WHAT APPEARED TO BE CRACK IN THE SHEATH. CHAR MARKS ON EXTERIOR OF EXTENDER AND OUTER PLASTIC COATING APPEARS MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLSEN BOVIE EXTENDER GEI OLSEN MEDICAL * 110802
    2 THERMOGARD DUAL DISPERSIVE ELECTRODE ODR CONMED CORPORATION * 0812171

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR