BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL GENERAL PACK

    MDR report key: 23726708 · Received December 5, 2025

    Report

    Report Number
    3005011024-2025-00015
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    October 1, 2025
    Report Date
    December 5, 2025
    Manufacturer
    DEROYAL INDUSTRIES, INC..
    Product Code
    LRO
    UDI-DI
    50749756281411
    PMA / PMN Number
    K842648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED VIA A MEDWATCH, "THERE WAS NOT RULER IN THE PACK. " DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT IT WAS LISTED AS NOT AVAILABLE FOR RETURN. DEROYAL REVIEWED THE WORK ORDER FOR THE LOT REPORTED WITH THE COMPLAINT AND DID NOT FIND ANY ISSUES. EMPLOYEES SIGNED OFF ON ADDING THE RULER TO THE PACK AS SPECIFIED. INVENTORY WAS NOT ABLE TO BE CHECKED AS NO INVENTORY WAS AVAILABLE AT DISTRIBUTION AND NO FURTHER INVENTORY IS BEING CREATED AS THE MANUFACTURING SITE HAS CLOSED. THE RISK ANALYSIS WAS REVIEWED AND WAS FOUND TO BE UP-TO-DATE AND DID NOT REQUIRE ANY UPDATES. A COMPLAINT TO SALES RATIO WAS CONDUCTED FOR OVER THE PAST TWO YEARS AND FOUND TO BE 0.011%. ROOT CAUSE: THE EXACT ROOT CAUSE WAS UNABLE TO BE DETERMINED AS NO ISSUES WERE DISCOVERED IN THE PRODUCTION RECORDS AND WITHOUT A RETURNED PRODUCT AND NO FURTHER INVENTORY BEING PRODUCED, NO FURTHER INFORMATION COULD BE GATHERED. CORRECTIVE AND PREVENTIVE ACTIONS: BECAUSE THE ROOT CAUSE WAS UNABLE TO BE DETERMINED AND BECAUSE THE MANUFACTURING SITE OF THE DEVICE, LAFOLLETTE, HAS CLOSED, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN. THERE IS NO OTHER ADDITIONAL INFORMATION AVAILABLE AS THE MANUFACTURING SITE OF THIS PRODUCT IN LAFOLLETTE, TENNESSEE HAS BEEN CLOSED. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE A FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THROUGH A MEDWATCH, "THERE WAS NOT RULER IN THE PACK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2857246 SMALL GENERAL PACK GENERAL SURGERY TRAY LRO DEROYAL INDUSTRIES, INC.. 89-2580 62457410 50749756281411

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown