BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ WAY, INC.

    MDR report key: 18162697 · Received November 17, 2023

    Report

    Report Number
    2183887-2023-00006
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Date of Event
    October 2, 2023
    Report Date
    October 26, 2023
    Manufacturer
    EZ WAY, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVOLVED IN THE INCIDENT HAS NOT BEEN RETURNED FOR OUR ANALYSIS.

    Additional Manufacturer Narrative · 0

    DEVICE INVOLVED IN THE INCIDENT HAS NOT BEEN RETURNED FOR OUR ANALYSIS. NEW INFORMATION - END USER STATES MODEL NUMBER AND SERIAL NUMBER OF SLING IS NOT READABLE, UDI INFORMATION CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    FACILITY STATED, "EZ WAY SLING RATED FOR 1000 LBS FAILED. FAILED WHEN THE BLACK LEG LOOP SPLIT WHILE THE STAFF WERE TRANSFERRING RESIDENT. RESIDENT FELL TO THE FLOOR, FALLING APPROXIMATELY 41 INCHES. NO MAJOR INJURY DETERMINED FROM THE FALL."

    Description of Event or Problem · 0

    FACILITY STATED, "EZ WAY SLING RATED FOR 1000 LBS FAILED. FAILED WHEN THE BLACK LEG LOOP SPLIT WHILE THE STAFF WERE TRANSFERRING RESIDENT. RESIDENT FELL TO THE FLOOR, FALLING APPROXIMATELY 41 INCHES. NO MAJOR INJURY DETERMINED FROM THE FALL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916445 EZ WAY, INC. SLING FSA EZ WAY, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female