BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLSEN

    MDR report key: 1348725 · Received March 12, 2009

    Report

    Report Number
    1530493-2009-00001
    Event Type
    Other
    Date Received
    March 12, 2009
    Date of Event
    January 23, 2009
    Report Date
    March 12, 2009
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS MANUFACTURED IN OCTOBER OF 2002, OVER SIX YEARS AGO AND WE NO LONGER SELL THIS MODEL. THE WARRANTY ON THIS DEVICE EXPIRED LONG AGO. WHEN THE END-USER WAS CONTACTED ON 2/19/2009 THE DEVICE WAS REQUESTED FOR AN EVALUATION AND THEY AGREED TO RETURN THE DEVICE. NO FOLLOW-UP TREATMENT WAS NEEDED OR GIVEN. THE DEVICE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    MANUFACTURER RECEIVED REPORT FROM END-USER ON 2/19/2009 AND THE FOLLOWING INFORMATION. "DURING A PARTIAL GLOSSECTOMY A SUPERFICIAL BURN WAS NOTED JUST RIGHT OF MIDLINE OF THE PT'S LOWER LIP AND CORRESPONDING TO THE EDGE OF THE BOVIE EXTENDER. EXTENDER WAS IMMEDIATELY REMOVED. THE INSIDE OIM OF THE EXTENDER, ABOUT 1/4 INCH IN, WAS NOTED TO HAVE WHAT APPEARED TO BE CRACK IN THE SHEETH. 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 ELECTRODE EXTENDER GEI OLSEN MEDICAL 67501 110802

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other