BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NURSE ASSIST, LLC

    MDR report key: 19845204 · Received July 26, 2024

    Report

    Report Number
    3002695476-2024-00046
    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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN EMAIL WAS SENT TO PRODUCT REMOVE INFO EMAIL ADDRESS BY (B)(6) ON 11/17/23. THE EMAIL WAS FORWARDED TO THE COMPLAINTS DEPARTMENT ON 6/27/24, 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 6/27/24 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: I USED NURSE ASSIST 0.9% SODIUM CHLORIDE IRRIGATION USP AND STERILE WATER FOR IRRIGATION OF BLADDER VIA CATHETER. 2 DAYS LATER WAS VERY SICK WITH HIGH FEVER, TACHYCARDIA AND GENERAL MALAISE. WALK IN CLINIC TESTS SHOWED HIGH LEVELS OF WHITE BLOOD CELLS AND REFERRED TO ER FOR IMMEDIATE EVALUATION. ER DIAGNOSED ME WITH ACUTE BACTERIAL PROSTATITIS AND SEPSIS. I WAS ADMITTED TO THE HOSPITAL THAT DAY FOR IV ANTIBIOTICS, FREQUENT BLOOD WORK AND OBSERVATION. I RESPONDED WELL THE TO TREATMENT AFTER 2 DAYS AND WAS RELEASED TO FINISH ANTIBIOTICS AT HOME. SINCE THEN I HAVE HAD MANY COMPLICATIONS FROM THIS INFECTION. MY UROLOGISTS TELL ME HEALING FROM THIS TYPE OF INFECTION IS SLOW AND THE DAILY PROSTATE PAIN I HAVE NOW MAY BE CHRONIC AND HERE TO STAY. THERE ARE LASTING EFFECTS. THIS PRODUCT HAS RECENTLY BEEN RECALLED FOR LACK OF STERILITY CONFIDENCE. AFTER THE INFECTION WE STRUGGLED TO UNDERSTAND THE SOURCE OF THE INFECTION AND RAPID NATURE OF THE INFECTION AS I'VE BEEN USING PRODUCTS LIKE THIS IN THIS MANNER FOR OVER 20 YEARS, AM VERY CAREFUL, AND HAVE NEVER HAD AN ISSUE LIKE THIS. THE FDA FORM SUGGESTIONS I SHOULD INFORM THE MANUFACTURER AS WELL AS FILE THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945853 NURSE ASSIST, LLC 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW TOP FRO NURSE ASSIST, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| H