BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOVIE PENCIL AND INSULATED COATED BLADE TIP

    MDR report key: 2083005 · Received May 4, 2011

    Report

    Report Number
    MW5020526
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 4, 2011
    Manufacturer
    VALLEY LAB
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING BILATERAL BREAST AUGMENTATION. AFTER UTILIZING THE BOVIE/TIP, THE SURGEON NOTED AN AREA OF ERYTHEMA ALONG THE INCISION LINE MEASURING APPROX 3MM IN LENGTH WHICH HE ATTRIBUTED TO THE COAGULATION DEVICE. UPON ADD'L INSPECTION OF THE CONTRALATERAL BREAST, THE SURGEON NOTED A SIMILAR AREA OF ERYTHEMA ALONG THE INCISION WHERE HE HAD PREVIOUSLY UTILIZED THE COAGULATION DEVICE. THIS AREA ALSO MEASURED APPROX 3MM IN LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOVIE PENCIL AND INSULATED COATED BLADE TIP BOVIE WITH BLADE TIP GEI VALLEY LAB 196782

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR