BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEY LAB

    MDR report key: 2892707 · Received December 21, 2012

    Report

    Report Number
    MW5028356
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    October 15, 2012
    Report Date
    December 21, 2012
    Manufacturer
    *
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INTRA-OPERATIVE PROCEDURE END OF SURGERY SMALL BURN NOTED AT RIGHT MIDLINE BELOW ABDOMINAL INCISION LINE, DOCTOR AWARE. CAUTERY UNIT WITH CAUTERY PENCIL AND ELECTRODE SENT TO BIO MED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALLEY LAB ELECTRODE GEI * * 231179
    2 VALLEY LAB CAUTERY PENCIL VALLEY GEI VALLEY LAB 23937

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR