BEUDAMED
    FDA Adverse Event Death Summary report: N

    NURSE ASSIST, LLC

    MDR report key: 18402522 · Received December 27, 2023

    Report

    Report Number
    3002695476-2023-00031
    Event Type
    Death
    Date Received
    December 27, 2023
    Date of Event
    September 22, 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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH REPORT MW5149035.

    Description of Event or Problem · 0

    ON 12-DEC-23, NURSE ASSIST RECEIVED A COMPLAINT VIA E-MAIL FROM FDA MEDWATCH OF THE FOLLOWING EVENT. DESCRIPTION FROM MEDWATCH REPORT: THERE WAS SO MANY TEST DONE ON MY MOTHER, I HAVE ALL OF HER MEDICAL RECORDS. HER ULCER WOUND GOT INFECTED WITH CANDIDA AURIS, WE WOULD WASH THE WOUND DAILY WITH WATER. SHE HAD WHITE SPORES FUNGI GROWTH AROUND THE WOUNDS AND SHE HAD A "CATHETER" AS WELL. THE HOSPITAL SAID THE CANDIDA AURIS GOT INTO HER BLOOD, SHE WENT INTO SEPTIC SHOCK AND DIED. I PURCHASED THE WATER FOR HER. IF I WOULD HAVE KNOWN THERE WAS ANY LIKELY HOOD OF KNOWN "ING", IT WAS NOT STERILE. I WOULD NEVER BROUGHT FOR HER BECAUSE I KNEW WE CANT USE TAP WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291061 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