BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGARD

    MDR report key: 18759620 · Received February 22, 2024

    Report

    Report Number
    3014527682-2024-00009
    Event Type
    Malfunction
    Date Received
    February 22, 2024
    Report Date
    February 22, 2024
    Manufacturer
    ROI CPS, LLC
    Product Code
    OJJ
    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 BY OUR FIRM. ROI CPS, LLC KITS WERE OBSERVED FROM RECEIVING THROUGH HANDLING, STORAGE, AND USE OF THE KITS AT THE USER FACILITY, WITH FACILITY STAFF PRESENT. THE CONCULSIONS DRAWN AND STORAGE AND HANDLING RECOMMENDATIONS TO THE FACILITY ARE ATTACHED TO THIS REPORT FOR REFERENCE.

    Description of Event or Problem · 0

    LARGE TEAR NOTED IN THE VENTED BAG BEFORE OPENING FOR CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67913 REGARD BURN PACK OJJ ROI CPS, LLC GS00082Y 98196

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown