BEUDAMED
    FDA Adverse Event Other Summary report: N

    C-SECTION TRAY-LF

    MDR report key: 1883275 · Received October 25, 2010

    Report

    Report Number
    1417592-2010-00066
    Event Type
    Other
    Date Received
    October 25, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED DURING A C-SECTION. IT WAS REPORTED THAT THE PEN BURNT THROUGH THE DRAPE LEAVING HOLES IN IT. A MINOR BURN TO THE PT ALSO RESULTED. A TOPICAL OINTMENT WAS APPLIED AND THE PT WAS REPORTED TO BE DOING WELL. UPON INSPECTION, THE ACCOUNT REPORTED THEY IDENTIFIED AN EXPOSED AREA ON THE CORD THAT WAS LOCATED APPROXIMATELY 3 FEET FROM THE PENCIL. THE CAUTERY PENCIL IS A CUSTOMER REQUESTED COMPONENT INSIDE A CUSTOM PACK. THE PENCIL IS A VALLEYLAB DEVICE MFG BY COVIDIEN. WE HAVE HAD NO OTHER SIMILAR REPORTS OF THIS NATURE FOR THIS DEVICE. THE SAMPLE WAS NOT RETURNED TO MEDLINE FOR EVAL. INSTEAD, THE ACCOUNT REPORTED THEY RETURNED THE SAMPLE TO COVIDIEN. COVIDIEN WILL INVESTIGATE THE INCIDENT AND DETERMINE THE NEED FOR ANY CORRECTIVE ACTION. HOWEVER, DUE TO THE REPORTED PT BURN, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    A PT WAS BURNED BY AN EXPOSED AREA ON THE CORD OF THE CAUTERY PENCIL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-SECTION TRAY-LF VALLEYLAB CAUTERY PENCIL WITH PACK GEI MEDLINE INDUSTRIES, INC. DYNJC2190D 10CB4962

    Patients

    Seq Age Sex Outcome Treatment
    1 Other