BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGARD

    MDR report key: 18746612 · Received February 21, 2024

    Report

    Report Number
    3014527682-2024-00004
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Date of Event
    January 2, 2024
    Report Date
    February 21, 2024
    Manufacturer
    ROI CPS, LLC
    Product Code
    LRO
    UDI-DI
    10194717113829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SITE VISIT TO THE FACILITY WHO REPORTED THIS EVENT WAS CONDUCTED AS PART OF THE INVESTIGATION. ROI CPS, LLC KITS WERE OBSERVED FROM RECEIVING THROUGH HANDLING, STORAGE, AND USE OF THE KITS. OBSERVERS INCLUDED ROI CPS, LLC PERSONNEL AS WELL AS PERSONNEL FROM THE USER FACILITY. THE CONCLUSIONS DRAWN FROM THE VISIT AND THE RECOMMENDATIONS TO THE FACILITY ARE ATTACHED TO THIS REPORT.

    Description of Event or Problem · 0

    HOLE DISCOVERED IN VENTED BAG. PACK WAS REMOVED AND REPLACED WITH STERILE ITEM FROM SUPPLY.

    Description of Event or Problem · 0

    HOLE DISCOVERED IN VENTED BAG. PACK WAS REMOVED AND REPLACED WITH STERILE ITEM FROM SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484120 REGARD MAJOR PACK LRO ROI CPS, LLC GS00086V 98266 10194717113829

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown