BEUDAMED
    FDA Adverse Event Other Summary report: N

    VALLEY LAB ELECTRICAL SURGICAL GENERATOR - BOVIE

    MDR report key: 1638245 · Received March 18, 2010

    Report

    Report Number
    MW5015234
    Event Type
    Other
    Date Received
    March 18, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 16, 2010
    Manufacturer
    VALLEY LAB
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A C-SECTION PROCEDURE, THE PHYSICIAN WAS USING THE BOVIE EQUIPMENT ON THE PATIENT WHEN THE PHYSICIAN NOTICED 2 SMALL BURNS ON THE PATIENT'S ABDOMEN. THE PHYSICIAN BELIEVES THE BOVIE MAY HAVE MALFUNCTIONED. THE HANDHELD PIECE OF THE EQUIPMENT WAS DISPOSABLE AND WAS THROWN OUT. THE VALLEY LAB ELECTRICAL SURGICAL GENERATOR WAS SENT TO BIO MED AND WAS CHECKED AND DETERMINED TO BE IN WORKING ORDER. PATIENT'S BURNS TREATED BY PHYSICIAN, AND ARE RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALLEY LAB ELECTRICAL SURGICAL GENERATOR - BOVIE BOVIE GEI VALLEY LAB FX-C

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other