BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER COLORADO ELECTRODE

    MDR report key: 2261110 · Received September 22, 2011

    Report

    Report Number
    2261110
    Event Type
    Injury
    Date Received
    September 22, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 25, 2011
    Manufacturer
    STERILE MED, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INSULATION ON (B)(4) BOVIE TIP FAILED RESULTING IN A BURN TO PATIENT'S LIP. (EQUIPMENT WAS IN USE AND ACTIVATED AT THE TIME OF THE INCIDENT.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER COLORADO ELECTRODE COLORADO TIP GEI STERILE MED, INC. STRN104A 4442368

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other