BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NURSE ASSIST, LLC

    MDR report key: 19529041 · Received June 13, 2024

    Report

    Report Number
    3002695476-2024-00026
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    February 1, 2023
    Report Date
    June 11, 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 THE PRODUCT REMOVAL INFO EMAIL ADDRESS BY (B)(6) ON 2/5/24. THE EMAIL WAS FORWARDED TO THE COMPLAINT DEPARTMENT ON 5/20/24, 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 5/20/24 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. ON 20-MAY-24, NURSE ASSIST FOLLOWED-UP WITH (B)(6) VIA E-MAIL AND RECEIVED A RESPONSE BACK FROM (B)(6) DESCRIPTION OF E-MAIL ON MONDAY, MAY 20, 2024: WE PURCHASED (3) THREE DIFFERENT LOTS. THEY WERE PURCHASE IN JANUARY 2023, 24 BOTTLES 250 ML. TWO LOTS. IN MID MARCH PURCHASED ANOTHER 24 250 ML. BOTTLES. THESE WERE PURCHASE THRU AMAZON. WE RECEIVED NOTIFICATION FROM AMAZON IN NOVEMBER OF 2023. THE STERILE WATER WS USED 3 TIMES PER DAY AT 50 ML FOR IRRIGATION OF NEO BLADDER. I DO NOT HAVE THE PICTURE OR LOT NUMBER OF THE STERILE WATER. THERE WAS KNOW INDICATION IN EARLY 2023 OF ANY TROUBLE WITH THE WATER. SOON AFTER USING THE STERILE WATER, I WAS DIAGNOSED WITH CKD. TO THIS DAY I'M DEALING WITH CKD.

    Description of Event or Problem · 0

    COMMENTS INCLUDED IN EMAIL RECEIVED FROM COMPLAINANT: I WAS NOTIFIED BACK IN NOVEMBER OF 2023 THAT THE WATER I PURCHASED FROM AMAZON TO FLUSH OUT MY NEOBLADDER (THIS IS A BLADDER THAT IS STRUCTURED OUT OF MY SMALL INTESTINES) HAD A RECALL ON IT. I ORDERED THE WATER ON JANUARY 16TH 2023, JANUARY 22ND 2023 AND MARCH 22ND 2023. I HAD MY BLADDER REMOVED ON (B)(6) OF 2023 DUE TO BLADDER CANCER AND WAS UNABLE TO GET ANY STERILE WATER FROM MY HOME CARE PROVIDER BECAUSE MEDICARE HAD NOT OK IT YET FROM THE DOCTOR BUT I HAD TO START FLUSHING OUT MY NEW NEOBLADDER AFTER RETURNING HOME FROM THE HOSPITAL. I ENDED BACK UP IN THE HOSPITAL WITH AN INFECTION IN FEBRUARY 2023 AND IT HAS BEEN RECURRING EVERY 6-8 WEEKS SINCE. I WOULD INJECT THE WATER INTO MY NEOBLADDER THOUGH MY CATHETER WITH A SYRINGE THEN SUCTION IT BACK OUT. THIS WAS TO REMOVE THE MUCUS SHEDDING FROM THE NEOBLADDER SO THAT IT WOULD NOT BUILD UP AND CAUSE ANY OBSTRUCTION TO THE KIDNEYS AND TO PREVENT UTI'S. I HAVE HAD TWO STRAINS OF INFECTIONS, ONE IS ENTEROCOCCUS AND PSEUDOMONAS WITH THOSE I HAVE HAD TO TAKE ANTIBIOTICS, THE ANTIBIOTIC WORK WELL ENOUGH FOR ME TO BE DISCHARGED FROM THE HOSPITAL BUT AFTER 6-8 WEEKS IT COMES BACK. THE PAST TWO TIMES I HAVE HAD A PICK LINE IN SO THAT MY WIFE AND I CAN ADMINISTER THE ANTIBIOTICS AT HOME. MY UROLOGIST HAS TOLD ME THAT I MAY BECOME RESILIENT TO THE ANTIBIOTICS AND NOW NEED TO BE PUT ON A MAINTENANCE ANTIBIOTIC FROM MY INFECTION DIESES DOCTOR. I HAVE GONE THOUGH OTHER PROCEDURES SINCE MY INITIAL REMOVAL SURGERY FOR STINTS TO BE PUT IN THE UTERI TUBE BETWEEN KIDNEYS AND NEOBLADDER AS WELL AS NEPHROISPY TUBES OUT MY BACK TO DRAIN BOTH THE LEFT AND RIGHT KIDNEY DUE TO UTERA BLOCKAGE. I FEEL THAT THE WATER THAT WAS PURCHASED COULD BE THE CULPRIT OF THE INFECTIONS I HAVE BEEN EXPERIENCING AND WANTED TO MAKE YOU AWARE. I WILL BE COMPLETING THE FDA QUESTIONNAIRE. ANY INFORMATION THAT YOU CAN PROVIDE TO ME WOULD BE GREATLY APPRECIATED. IIF YOU HAVE ANY QUESTIONS PLEASE LET ME KNOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123736 NURSE ASSIST, LLC STERILE WATER FOR IRRIGATION USP IN SCREW BOTTLE TOP FRO NURSE ASSIST, LLC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R| L