BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J-PLASMA HANDPIECE

    MDR report key: 6200517 · Received December 22, 2016

    Report

    Report Number
    3007593903-2016-00013
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    August 17, 2016
    Report Date
    December 22, 2016
    Manufacturer
    BOVIE MEDICAL CORPORATION
    Product Code
    GEI
    UDI-DI
    10607151007819
    PMA / PMN Number
    K112233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER NOTIFIED OF ALLEGATIONS OF PATIENT INJURIES FROM A J-PLASMA PROCEDURE IN THE FACE AND NECK AREA. REPORTER CONFIRMED THAT THE PATIENT HAD SUBSEQUENT TREATMENTS SUCH AS: IPL AND MICRO NEEDLING. NO ALLEGATION OF DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THE EVENT WAS NOTIFIED BE BOVIE MEDICAL SALE REPRESENTATIVE. A FACE AND NECK RESURFACING PROCEDURE WAS PERFORMED ON PATIENT WHO HAS SINCE COMPLAINED OF SCARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850188 J-PLASMA HANDPIECE GS-018C GEI BOVIE MEDICAL CORPORATION 0616G 10607151007819

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention