BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESIDENT LIFT DEVICE EZ STAND PREMIER

    MDR report key: 12828498 · Received November 16, 2021

    Report

    Report Number
    MW5105370
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    November 7, 2021
    Report Date
    November 12, 2021
    Manufacturer
    EZ WAY INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RESIDENT OF SKILLED NURSING FACILITY WAS BEING LIFTED WITH AN EZ STAND WHEN STAND BROKE IN 1/2. RESIDENT FELL TO THE FLOOR HITTING HIS HEAD. RESIDENT EVALUATED AT FACILITY WITH MINOR INJURIES. RESIDENT SENT TO ER FOR FURTHER EVALUATION DUE TO HEAD INJURY. SCANS INDICATED NO ADDITIONAL INJURIES WERE SUSTAINED AND RESIDENT RETURNED TO THE SKILLED NURSING FACILITY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716328 RESIDENT LIFT DEVICE EZ STAND PREMIER LIFT, PATIENT, NON-AC-POWERED FSA EZ WAY INC. 896

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Male Other