BEUDAMED
    FDA Adverse Event Death Summary report: N

    NURSE ASSIST, LLC

    MDR report key: 18402520 · Received December 27, 2023

    Report

    Report Number
    3002695476-2023-00030
    Event Type
    Death
    Date Received
    December 27, 2023
    Date of Event
    December 1, 2023
    Report Date
    December 21, 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

    REPORTER'S SPOUSE DIED IN (B)(6) 2022.

    Description of Event or Problem · 0

    ON 01-DEC-23, NURSE ASSIST RECEIVED A COMPLAINT VIA E-MAIL FROM (B)(6) OF THE FOLLOWING EVENT. DESCRIPTION FROM NURSE ASSIST CUSTOMER SERVICE E-MAIL: THANK YOU FOR RETURNING MY CALL RELATED TO MY CONCERNS ABOUT THE NURSE ASSIST, INC. STERILE WATER I USED FROM (B)(6) 2022 WHILE I WAS CARING FOR MY HUSBAND UNTIL HE DIED. AT YOUR REQUEST, THE FOLLOWING IDENTIFIES THE PURCHASE THAT I MADE FROM AMAZON: ITEM: STERILE WATER FOR IRRIGATION USP/ STERICARE SOLUTIONS 250 ML ITEM NUMBER: 6260 LOT #: 22073568 EXP: 2024-07-05 I LOOK FORWARD TO HEARING FROM YOU REGARDING THIS MATTER. ON 11-DEC-23, NURSE ASSIST RECEIVED MORE INFORMATION RELATING TO THE EVENT FROM JOYCE A. CLAMPITT DESCRIPTION FROM E-MAIL: YOUR QUESTION: CAN YOU PLEASE DESCRIBE THE ISSUE THAT YOU HAD REGARDING THE USE OF OUR PRODUCT, ALONG WITH HOW YOU USED OUR PRODUCT? ANSWER: THE ISSUE THAT I HAVE REGARDING YOUR PRODUCT, STERILE WATER FOR IRRIGATION USP/STERICARE SOLUTIONS 250 ML, IS THAT AMAZON NOTIFIED ME RECENTLY ABOUT A CONCERN WITH THE PRODUCT. IN RESPONSE TO A REQUEST, I PROVIDED THE LOT #22073568 INVOLVED. I USED THE PRODUCT WHILE CARING FOR MY HUSBAND DURING A PERIOD BETWEEN (B)(6) 2022, AT WHICH TIME HE DIED. YOUR QUESTION: HOW MANY AFFECTED BOTTLES DO YOU HAVE? ANSWER: I CURRENTLY HAVE 6 UNOPENED BOTTLES AND 1 OPENED BOTTLE WHICH HAS APPROXIMATELY ¼ OF THE WATER REMAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291059 NURSE ASSIST, LLC STERILE WATER FOR IRRIGATION USP, IN SCREW TOP BOTTLE FRO NURSE ASSIST, LLC 6260 22073568

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| R| O