BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDGE INSUL. COATED BLADE

    MDR report key: 2213106 · Received August 9, 2011

    Report

    Report Number
    1717344-2011-00667
    Event Type
    Injury
    Date Received
    August 9, 2011
    Report Date
    July 14, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED, OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN ABDOMINAL PROCEDURE, THERE WAS A DEFECT IN THE INSULATION OF THE ELECTRODE WHICH CAUSED A 4X2 CM BURN ON THE PT'S HEALTHY SKIN SURFACE RATHER THAN WHERE IT WAS INTENDED. THE 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 INSUL. COATED BLADE COATED ELECTRODE GEI COVIDIEN LP (VALLEYLAB) 207059X

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other