BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NURSE ASSIST, LLC

    MDR report key: 19845201 · Received July 26, 2024

    Report

    Report Number
    3002695476-2024-00045
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    June 9, 2023
    Report Date
    July 3, 2024
    Manufacturer
    NURSE ASSIST, LLC
    Product Code
    FRO
    PMA / PMN Number
    K083042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN EMAIL WAS SENT TO PRODUCT REMOVE INFO EMAIL ADDRESS BY (B)(6) ON 11/08/2023. THE EMAIL WAS FORWARDED TO THE COMPLAINTS DEPARTMENT ON 6/27/2024, 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 COMPLAINTS DEPARTMENT ON 6/27/2024 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: I AM ENCLOSING THE FDA 3500 FORM THAT IS REPORTING MY INFORMATION. (B)(6). DESCRIPTION ON FDA 3500 FORM: I USED THIS PRODUCT IN A VAPORIZER, I GOT A LUNG INFECTION THAT CAUSED A DEEP COUGH THAT LASTED ABOUT 3 MONTHS. I ALSO DEVELOPED C.O.P.D WHICH I HAD NEVER BEEN DIAGNOSED WITH PREVIOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945850 NURSE ASSIST, LLC STERILE WATER FOR IRRIGATION USP IN SCREW TOP FRO NURSE ASSIST, LLC 6290 22022728

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other