BEUDAMED
    FDA Adverse Event Death Summary report: N

    NURSE ASSIST, LLC

    MDR report key: 18387517 · Received December 22, 2023

    Report

    Report Number
    3002695476-2023-00014
    Event Type
    Death
    Date Received
    December 22, 2023
    Date of Event
    November 20, 2023
    Report Date
    December 21, 2023
    Manufacturer
    NURSE ASSIST, LLC
    Product Code
    FRO
    UDI-DI
    00612479199576
    PMA / PMN Number
    K083042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WE RECEIVED A MEDWATCH FROM THE FDA, BUT NEITHER THE ANONYMOUS REPORTER NOR THE FDA WOULD OR COULD PROVIDE ANY INFORMATION THAT WOULD ALLOW US TO CONDUCT A MEANINGFUL INVESTIGATION. WE ARE THEREFORE FILING AN MDR BASED ON THE MEDWATCH BUT CANNOT MAKE ANY DETERMINATION AS TO WHETHER THE REPORTED EVENT ACTUALLY HAPPENED, AND IF IT DID WHETHER IT INVOLVED OUR PRODUCTS, AND IF IT DID WHETHER THOSE PRODUCTS ACTUALLY CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    ON 28-NOV-23, NURSE ASSIST RECEIVED A MEDWATCH REPORT (MW5148357) VIA E-MAIL OF THE FOLLOWING EVENT DESCRIPTION FROM MEDWATCH REPORT: CDER RECEIVED THE MEDWATCH REPORT. THE REPORTER STATES THE IMPACTED INDIVIDUAL HAD AN ULCER WOUND THAT GOT INFECTED WITH CANDIDA AURIS. THEY WASHED THE WOUND DAILY WITH WATER. THERE WERE WHITE SPORES (FUNGAL GROWTH) AROUND THE WOUNDS. THE HOSPITAL DETERMINED THAT CANDIDA AURIS GOT INTO THE BLOOD STREAM OF THE IMPACTED INDIVIDUAL AND THE INDIVIDUAL WENT INTO SEPTIC SHOCK AND DIED. THE REPORTER STATED THAT THEY HAVE THE MEDICAL RECORDS FOR THE DECEASED INDIVIDUAL. INFECTION LEADING TO DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570066 NURSE ASSIST, LLC 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW TOP BOTTLE FRO NURSE ASSIST, LLC 37-6270 22083817 00612479199576

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death