BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J-PLASMA

    MDR report key: 8613029 · Received May 15, 2019

    Report

    Report Number
    3007593903-2019-00006
    Event Type
    Injury
    Date Received
    May 15, 2019
    Date of Event
    December 12, 2018
    Report Date
    April 17, 2019
    Manufacturer
    BOVIE MEDICAL CORPORATION
    Product Code
    GEI
    UDI-DI
    00607151011871
    PMA / PMN Number
    K151325
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTED COMPLAINT FOR ACUTE RIGHT CHEST WALL HEMATOMA FOLLOWING SURGERY. BLOOD PRESSURE UPON PRESENTATION WAS 190/110. RIGHT CHEST WALL WAS EVACUATED OF A 350CC HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406540 J-PLASMA J-PLASMA GEI BOVIE MEDICAL CORPORATION J-PLASMA 0918E 00607151011871

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention