BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NURSE ASSIST, LLC

    MDR report key: 19826521 · Received July 25, 2024

    Report

    Report Number
    3002695476-2024-00041
    Event Type
    Injury
    Date Received
    July 25, 2024
    Report Date
    July 2, 2024
    Manufacturer
    NURSE ASSIST, LLC
    Product Code
    FRO
    UDI-DI
    00850421008839
    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 PRODUCT REMOVE INFO EMAIL ADDRESS BY (B)(6) ON (B)(6) 2023. THE EMAIL WAS FORWARDED TO THE COMPLAINTS DEPARTMENT ON (B)(6) 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 (B)(6) 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 HAVE ORDERED THIS PRODUCT TWICE TO IRRIGATE MY WIFE'S KIDNEY STENT SINCE HER BLADDER WAS REMOVED BECAUSE OF CANCER. I FULLY USED THE FIRST 500ML CONTAINER AND JUST OPENED THE SECOND. OBVIOUSLY, I WILL NOT USE THE PRODUCT GOING FORWARD. I HAVE ATTACHED FILES SHOWING THE PRODUCT I PURCHASED AND THE ORDER FROM AMAZON. I HAVE ALREADY FOUND ANOTHER SOURCE FOR THIS PRODUCT. I HAVE NO WAY OF KNOWING, BUT MY WIFE, (B)(6) , HAS BEEN HOSPITALIZED 3 TIMES SINCE THE STENT WAS INSTALLED BECAUSE OF KIDNEY FAILURE DUE TO INFECTION. OBVIOUSLY I AM VERY CAUTIOUS OF ANYTHING THAT CAN DO HARM TO HER AS SHE WORKS TO RECOVERS FROM THE CANCER SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365350 NURSE ASSIST, LLC 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW BOTTLE TOP FRO NURSE ASSIST, LLC 6280 22104139 00850421008839

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R