BEUDAMED
    FDA Adverse Event Death Summary report: N

    J-PLASMA

    MDR report key: 17374078 · Received July 20, 2023

    Report

    Report Number
    MW5119814
    Event Type
    Death
    Date Received
    July 20, 2023
    Date of Event
    July 3, 2023
    Report Date
    July 15, 2023
    Manufacturer
    APYX MEDICAL CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ACCORDING TO DOCTOR HE HAD PERFORMED LIPOSUCTION ON NECK AND ABDOMEN AND HAD GONE BACK TO REFORM "SKIN TIGHTENING" WITH J-PLASMA WHEN MY DAUGHTER, (B)(6) CODED. AMBULANCE WAS CALLED AND SHE WAS TAKEN TO CEDARS SINAI WHERE IT WAS DETERMINED SHE SUFFERED CATASTROPHIC BRAIN DAMAGE INCONSISTENT WITH LIFE. SHE WAS REMOVED FROM THE EMCO (EXTRACORPOREAL MEMBRANE OXYGENATION) AND RESPIRATOR AND VENTILATOR ON (B)(6) 2023 AND PASSED AWAY MINUTES LATER. CORONERS INVESTIGATION IS PENDING. ALSO SECOND AUTOPSY WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771878 J-PLASMA ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI APYX MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Death| L| H "OWLBREE" 200 MG 1XQD PRISTIQ 100MG 1XQD (GENERIC)