BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDGE

    MDR report key: 2180625 · Received July 22, 2011

    Report

    Report Number
    2180625
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 14, 2011
    Manufacturer
    COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    THE EXTENDED BOVIE TIP HAS INSULATION ON IT; HOWEVER, THERE WAS A DEFECT IN THE INSULATION WHICH CAUSED A 4X2 CM BURN ON HEALTHY SKIN SURFACE RATHER THAN WHERE IT WAS INTENDED. DOCTOR HAD TO EXCISE THE BURNED SKIN AND CLOSE THE WOUND WITH SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDGE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE * 207059X

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention