BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEGADYNE

    MDR report key: 3955774 · Received July 18, 2014

    Report

    Report Number
    MW5037369
    Event Type
    Other
    Date Received
    July 18, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEGADYNE MEDICAL
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) Y/O WITH WOUND INFECTION. DURING DEBRIDEMENT OF WOUND INFECTION, MD OBSERVED THAT THE BOVIE PENCIL WAS MALFUNCTIONING. THE BOVIE PENCIL CAME FROM THE STERILE GENERAL TRAUMA PACK. LOT# 143540, EXP DATE: 05/01/2018, MFG DATE: 02/20/2014, CAT #SBAMHGTBHJ, BOVIE PENCIL DID HAVE A BOVIE TIP. ANOTHER BOVIE PENCIL WAS PLACED ON THE FIELD AND WAS ABLE TO FUNCTION PROPERLY. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423188 MEGADYNE BOVIE PENCIL GEI MEGADYNE MEDICAL 143540

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR STERILE GENERAL TRAUMA PACK: LOT #143540,| CAT #SBAMHGTBHJ| EXP DATE: 05/01/2018, MFG DATE: 02/20/2014,