BEUDAMED
    FDA Adverse Event Death Summary report: N

    NURSE ASSIST, LLC

    MDR report key: 18387502 · Received December 22, 2023

    Report

    Report Number
    3002695476-2023-00024
    Event Type
    Death
    Date Received
    December 22, 2023
    Date of Event
    November 9, 2023
    Report Date
    December 19, 2023
    Manufacturer
    NURSE ASSIST, LLC
    Product Code
    FRO
    PMA / PMN Number
    K083042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WAS UNABLE TO RECEIVE LOT NUMBER FROM CONSUMER.

    Description of Event or Problem · 0

    ON 09-NOV-23, NURSE ASSIST RECEIVED A COMPLAINT VIA PHONE FROM OLIVIA MCFALLAR OF THE FOLLOWING EVENT DESCRIPTION FROM NURSE ASSIST CUSTOMER SERVICE E-MAIL: IN 1 WEEK, 4 DIFFERENT SALINE SPRAY WOUND CARE PRODUCTS WERE PURCHASED FROM WALMART ONLINE. SHE DID NOT HAVE THE INVOICES AVAILABLE AT THE TIME OF THE CALL, TO PROVIDE WHICH 4 PRODUCTS WERE PURCHASED. SHE USED THE SPRAYS TO TREAT MINOR WOUNDS WHILE CARING FOR HER GRANDMOTHER. FROM MEMORY, SHE SAID: · BANDAID BRAND. · MCKESSON BRAND. · (UNKNOWN AT TIME OF CALL). · (UNKNOWN AT TIME OF CALL). GRANDMOTHER HAD A MINOR WOUND THAT WAS TREATED BY ONE OF THE SPRAYS, "MUST HAVE BEEN YOURS", DEVELOPED AN INFECTION THAT RAPIDLY DEVELOPED INTO GANGRENE. GRANDMOTHER THEN PASSED AWAY IN A MATTER OF DAYS. THE CALLER WAS GRIEVING AND THREW AWAY THE PRODUCTS THE FOLLOWING DAY, AS THEY WERE NO LONGER NEEDED FOR CARING FOR GRANDMOTHER. SHE DOES NOT HAVE THE LOT #S, AND COULD NOT TELL ME WHAT THE OTHER 2 PRODUCT BRANDS WERE, BUT SWEARS THAT OUR RECALLED SALINE SPRAY HAS TO BE RESPONSIBLE FOR THE INFECTION AND DEATH, BASED ON THE RECALL NOTIFICATION THAT SHE RECEIVED FROM WALMART. SHE WAS DRIVING AT THE TIME OF THE CALL AND DID NOT HAVE ACCESS TO THE WALMART ORDER HISTORY, TO GIVE ME THE 3RD PARTY SELLER INFORMATION. I TOLD HER TO CONTACT THOSE 3RD PARTY SELLERS WHEN SHE GETS HOME, TO REQUEST REFUNDS. AT THIS TIME, WE DO NOT HAVE THE OTHER 2 BRAND NAMES OR ANY OF LOT #S, TO TRACE THE PRODUCTS SOLD ON WALMART'S WEBSITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232679 NURSE ASSIST, LLC STERILE SALINE SPRAY CAN FRO NURSE ASSIST, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death