BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEC-PEN

    MDR report key: 131016 · Received November 5, 1997

    Report

    Report Number
    131016
    Event Type
    Injury
    Date Received
    November 5, 1997
    Date of Event
    October 28, 1997
    Report Date
    November 4, 1997
    Manufacturer
    EDWARD WECK INC.
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS DISSECTING TISSUE AROUND LEFT INTERNAL MAMMARY ARTERY USING THE COAGULATION OF THE WEC FOOT CONTROL CAUTERY. A SPARK FROM THE CAUTERY IGNITED A 4 X 4 GAUZE PAD. PAD REMOVED FROM SURGICAL FIELD. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WEC-PEN FOOT CONTROL ELECTROSURGICAL PENCIL GEI EDWARD WECK INC. * 016A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention