BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPUS PLASMA

    MDR report key: 18186153 · Received November 21, 2023

    Report

    Report Number
    3004450661-2023-00017
    Event Type
    Death
    Date Received
    November 21, 2023
    Date of Event
    November 12, 2023
    Report Date
    November 21, 2023
    Manufacturer
    ALMA LASERS LTD
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CUSTOMER NOTIFIED ALMA LASERS INC. OF A PATIENT'S DEATH WHICH WAS LIKELY CAUSED BY A BLOOD CLOT. CUSTOMER INFORMED ALMA LASERS AS THE PATIENT RECEIVED AN OPUS PLASMA TREATMENT 4 DAYS PRIOR TO PASSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880057 OPUS PLASMA OPUS PLASMA GEI ALMA LASERS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Death