BEUDAMED
    FDA Adverse Event Injury Summary report: N

    400 LB SMART STAND

    MDR report key: 23368152 · Received October 23, 2025

    Report

    Report Number
    2183887-2025-00006
    Event Type
    Injury
    Date Received
    October 23, 2025
    Date of Event
    October 4, 2025
    Report Date
    October 23, 2025
    Manufacturer
    EZ WAY INC
    Product Code
    FSA
    UDI-DI
    848914000149
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FACILITY HAD A FALL WITH THE EZ STAND AND RESULTED IN LEFT PROXIMAL HUMERUS FRACTURE AND RIGHT HIP FRACTURE. I NURSING ASSISTANT 1 EXPLANATION: RESIDENT WAS IN EZ STAND. RESIDENT ASKED TO GO DOWN, SO WE PUT HER ON COMMODE, BUT SHE WASN'T ON ALL THE WAY. WE HAD TO RAISE HER BACK UP AND THEN SHE STARTED YELLING "IT HURTS" "PUT ME DOWN" RESIDENT BEGAN SLIPPING DOWN AND SLIPPED PAST THE COMMODE. I HELPED HER DOWN AND THEN I RADIOED FOR HELP. NURSING ASSISTANT 2 EXPLANATION: WE WERE GOING TO PUT HER ON TOILET AND AS WE MOVED HER IT SEEMED LIKE HER LEGS GAVE OUT AND WE TRIED TO SET HER ON THE TOILET IT SEEMED LIKE SHE LET GO OF EZ STAND WITH HER HANDS STAFF EDUCATION NURSE THINKS THE RESIDENT SLIPPED THROUGH THE BOTTOM OF THE HARNESS. THE HARNESS HAD TO BE BELTED ABOVE HER CHEST BECAUSE THE RESIDENT IS VERY ENDOWED. SAID THE STAND DID NOT CAUSE THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699059 400 LB SMART STAND STAND FSA EZ WAY INC S400PN 848914000149

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Hospitalization| R