BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NURSE ASSIST, LLC

    MDR report key: 19845223 · Received July 26, 2024

    Report

    Report Number
    3002695476-2024-00044
    Event Type
    Injury
    Date Received
    July 26, 2024
    Report Date
    July 2, 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 PRODUCT REMOVE INFO EMAIL ADDRESS BY (B)(6) ON 11/08/23. THE EMAIL WAS FORWARDED TO THE COMPLAINTS DEPARTMENT ON 6/26/24, 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 6/26/24 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: RECEIVED WORD FROM AMAZON ABOUT THE RECALL. OUR INFO FROM THEIR ORDERS: PRODUCT: MCKESSON STERILE WATER, USP, SINGLE PATIENT USE, NOT FOR INJECTION, 250 ML, 24 COUNT. ORDER ID: (B)(6). PRODUCT: STERILE IRRIGATION WATER 250ML 24 BOTTLES. ORDER ID: (B)(6). THE RECALL ALSO STATES THAT TO DATE, NURSE ASSIST, LLC HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THESE PRODUCTS. WE MAY NEED TO CHANGE THAT: OUR DAUGHTER HAS NEUROGENIC BLADDER AND BOWEL; WE USE SALINE FOR BOWEL MANAGEMENT AND STERILE WATER FOR BLADDER MANAGEMENT (INCLUDING GIVING OXYBUTYNIN INTRAVESICALLY). OVER THE PAST COUPLE OF MONTHS, SHE'S BEEN FIGHTING UTIS OF DIFFERING BACTERIA, WHEN SHE HADN'T HAD UTI ISSUES FOR YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561759 NURSE ASSIST, LLC STERILE WATER FOR IRRIGATION USP IN SCREW TOP FRO NURSE ASSIST, LLC 37-6260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other