BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J-PLASMA

    MDR report key: 6962227 · Received October 19, 2017

    Report

    Report Number
    3007593903-2017-00008
    Event Type
    Injury
    Date Received
    October 19, 2017
    Report Date
    October 19, 2017
    Manufacturer
    BOVIE MEDICAL CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IS EXPERIENCING PROLONGED HEALING TIME AFTER FACIAL RESURFACING WITH J-PLASMA PROCEDURE. PATIENT WENT TO ER FOR TREATMENT FOLLOWING THE PROCEDURE. PATIENT IS NOW SEEING A DERMATOLOGIST FOR FOLLOW-UP TREATMENTS.

    Description of Event or Problem · 1

    PATIENT EXPERIENCING PROLONGED HEALING AFTER FACIAL RESURFACING WITH J-PLASMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741989 J-PLASMA J-PLASMA HANDPIECE GEI BOVIE MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention