BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEC-PEN FTC

    MDR report key: 501489 · Received December 17, 2003

    Report

    Report Number
    501489
    Event Type
    Injury
    Date Received
    December 17, 2003
    Date of Event
    October 28, 2003
    Report Date
    November 26, 2003
    Manufacturer
    WEC CLOSURE SYSTEMS
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE PT'S SURGICAL PROCEDURE THE WEC PEN WAS PLACED ON THE PT'S THIGH. THE PEN REMAINED ON, BURNING THE PT THROUGH THE IOBAN DRAPE. THE PEN WAS REMOVED FROM THE PT AND DID NOT TURN OFF UNITL THE ELECTROCAUTERY UNIT WAS UNPLUGGED. THE SURGEON EXCISED THE BURN DURING THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WEC-PEN FTC ELECTROSURGICAL PENCIL & CORD GEI WEC CLOSURE SYSTEMS * 179A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention VALLEY LAB FORCE 2 ELECTROCAUTERY UNIT, BOVIE PAD.