BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NURSE ASSIST, LLC

    MDR report key: 19614888 · Received June 26, 2024

    Report

    Report Number
    3002695476-2024-00039
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    November 8, 2023
    Report Date
    June 20, 2024
    Manufacturer
    NURSE ASSIST, LLC
    Product Code
    FRO
    UDI-DI
    00850421008778
    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 BY (B)(6) ON 11/08/23. THE EMAIL WAS FORWARDED TO THE COMPLAINTS DEPARTMENT ON 6/13//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 COMPLAINTS DEPARTMENT ON 6/13/24 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: WE HAVE CONTINUOUSLY USE THIS PRODUCT TO FLUSH MY HUSBAND'S CATHETER 4 TIMES A WEEK AND HAVE BEEN FOR A VERY LONG TIME. SOMEONE NEEDS TO REACH OUT TO ME ASAP TO FULLY EXPLAIN THE WARNING TO STOP USING IMMEDIATELY. HE HAS BEEN HAVING A LOT OF ISSUES WITH WHITE FLOATING SUBSTANCES CLOGGING HIS CATHETER CAUSING MULTIPLE TRIPS TO THE DOCTOR. MY HOME NUMBER IS (B)(6) AND MY NAME IS (B)(6). WE HAVE TWO ORDERS HERE TO RETURN BUT I'M MORE CONCERNED ABOUT THE FULL REASON OF THE RECALL AND WHAT IS SAFE TO USE IN ITS PLACE STARTING TOMORROW. WHEN ATTEMPTING TO CALL, THERE WAS NO ANSWER AND THE MAILBOX IS FULL SO I COULD NOT LEAVE A MESSAGE AND NO ONE IS ANSWERING. I AM EST SO PLEASE REACH BACK OUT ASAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550347 NURSE ASSIST, LLC STERILE WATER FOR IRRIGATION USP IN SCREW BOTTLE TOP FRO NURSE ASSIST, LLC 6260 00850421008778

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other