BEUDAMED
    FDA Adverse Event Injury Summary report: N

    500 LB SMART LIFT

    MDR report key: 22912837 · Received August 28, 2025

    Report

    Report Number
    2183887-2025-00003
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    May 14, 2025
    Report Date
    August 28, 2025
    Manufacturer
    EZ WAY INC
    Product Code
    FSA
    UDI-DI
    00848914000057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EDUCATOR AND TRANSITIONAL CARE UNIT SUPERVISOR AND DON INVESTIGATED THE INCIDENT THE SAME DAY. INTERVIEWED THE STAFF INVOLVED AND FOUND THIS WAS A SLING /USER ERROR.

    Description of Event or Problem · 0

    STAFF WERE TRYING TO RAISE THE RESIDENT FROM HIS WHEELCHAIR AND PUT HIM ON THE BED. BECAUSE OF THE WAY THE RESIDENT WAS IN THE SLING, AND THE KIND OF SLING USED, HE FLIPPED FORWARD AND LANDED ON THE FLOOR. HIS INJURIES WERE A MAXILLARY FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519399 500 LB SMART LIFT LIFT FSA EZ WAY INC L500PS-03 00848914000057

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Required Intervention| H