BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NURSE ASSIST, LLC

    MDR report key: 19569602 · Received June 19, 2024

    Report

    Report Number
    3002695476-2024-00030
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    December 22, 2023
    Report Date
    June 17, 2024
    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

    AN EMAIL WAS SENT TO PRODCT REMOVAL INFO EMAIL ADDRES BY (B)(6) ON DECEMBER 22, 2023. THE EMAIL WAS FORWARDED TO THE COMPLAINTS DEPARTMENT ON 5/21/24, WHICH INITIATED NURSE ASSIST'S INVESTIGATION OF THE REPORTED INCIDENT AND DETERMINATION THAT THE NOTED INCIDENT WAS REPORTABLE. A FOLLOW-UP EMAIL WAS SENT TO (B)(6). BY THE COMPLAINT DEPARTMENT ON 5/21/24, 6/10/2024, AND 6/17/2024 REQUESTING ADDITIONAL INFORMATION TO AID WITH REPORTING AND WITH THE INVESTIGATION. THE PRODUCT REMOVAL INFO EMAIL ADDRESS WAS INTENDED TO BE USED SOLELY FOR FACILITATING RETURN AND REPLACEMENT OF PRODUCT AND WAS NOT BEING REVIEWED FOR COMPLAINT INFORMATION, WHICH RESULTED IN THE DELAY OF REPORTING THIS INCIDENT. THE PRODUCT REMOVAL INFO EMAIL INBOX IS BEING EXPEDITIOUSLY REVIEWED TO IDENTIFY ANY OTHER INCIDENT RELATED INFORMATION THAT WOULD BE CONSIDERED AS A COMPLAINT.

    Description of Event or Problem · 0

    COMMENTS INCLUDED IN EMAIL RECEIVED FROM COMPLAINTS: MY DAUGHTER HAS RECEIVED THE RECALL PRODUCTS FROM YOUR COMPANY AND HAS USED THE PRODUCTS. NO ONE FROM YOUR COMPANY HAS EVER NOTIFIED US OF THE RECALLS. SHE HAS BEEN SICK AND EVEN HOSPITALIZED SEVERAL TIMES. YOUR FAILURE TO INFORM YOUR PATIENTS OF THE RECALL IS COMPLETELY UNACCEPTABLE. I AM FILING A COMPLAINT AND REQUESTING TO SPEAK WITH A MANAGER REGARDING THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677967 NURSE ASSIST, LLC 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW BOTTLE TOP FRO NURSE ASSIST, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O