BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NURSE ASSIST, LLC

    MDR report key: 19529030 · Received June 13, 2024

    Report

    Report Number
    3002695476-2024-00028
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    December 5, 2023
    Report Date
    June 11, 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 THE PRODUCT REMOVAL INFO EMAIL ADDRESS BY (B)(6) ON (B)(6) 2024. 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.

    Description of Event or Problem · 0

    COMMENTS INCLUDED IN EMAIL RECEIVED FROM COMPLAINANT: I AM EMAILING REGARDING THE ATTACHED PRODUCT RECALL. THIS RECALLED SOLUTION WAS USED IN MY DOG'S SURGERY ON (B)(6) AND RESULTED IN A SEVERE ABDOMINAL INFECTION AND THE NEED FOR A SECOND CORRECTIVE SURGERY IN THE DAYS FOLLOWING. I HAVE BEEN WORKING WITH THE (B)(6)VET'S OFFICE BUT HAVE NOT RECEIVED COMMUNICATION FOR NEXT STEPS. I PAID FOR THE SECOND EMERGENCY SURGERY, MEDICATION, AND MULTIPLE NIGHTS IN THE VETERINARY HOSPITAL OUT OF POCKET DUE TO THIS "NON-STERILE" MISTAKE. LUCKILY MY DOG AVOIDED SEPSIS AND SURVIVED THE TRAUMA. I BELIEVE I AM OWED COMPENSATION FOR THIS. PLEASE GET BACK TO ME AS SOON AS POSSIBLE WITH NEXT STEPS. LOT NUMBER: 23065871. EXPIRATION JUNE 20, 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784221 NURSE ASSIST, LLC 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW BOTTLE TOP FRO NURSE ASSIST, LLC 6280 23065871 00850421008839

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R