BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYCARE BED

    MDR report key: 18964413 · Received March 22, 2024

    Report

    Report Number
    3009402404-2024-00012
    Event Type
    Injury
    Date Received
    March 22, 2024
    Date of Event
    February 20, 2024
    Report Date
    March 22, 2024
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT OR OTHER INFORMATION SUBMITTED BY JOERNS HEALTHCARE UNDER 21 CFR PART 803, AND RELEASE BY FDA OF THAT REPORT INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY JOERNS HEALTHCARE , ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES, FINISHED DEVICE SUPPLIERS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT DURING A PREVIOUS MOVE OF THE BED FRAME ONE OF THE BLACK END CAPS THAT GO ON THE WIDTH EXTENSIONS HAD FALLEN OFF AND WERE NEVER REPLACED. WHEN THE MORNING STAFF WENT TO GET THE PT OUT OF BED THEY NOTICED A CUT ON THE LEG. PER STAFF, THE WOUND WAS NOT SERIOUS AND WAS ADDRESSED WITH BANDAGES, NO FURTHER ACTION NEEDED, AND "SHE WILL NOT BE DOING ANYTHING ABOUT IT TO THE FACILITY OR JHC". THE ORDER REFERENCED IS THE ORDER FOR THOSE BLACK PLASTIC CAPS TO REPLACE THE ONE(S) THAT HAVE FALLEN OFF ON THAT FRAME AND MAY BE MISSING ON OTHER FRAMES. COMPLAINT #(B)(4) WAS ENTERED INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928166 EASYCARE BED PATIENT BED FNL JOERNS HEALTHCARE ECS 5/6

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Other