BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTION COMPOSITES HELIO A7

    MDR report key: 23466012 · Received November 4, 2025

    Report

    Report Number
    MW5178493
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    September 29, 2025
    Report Date
    October 30, 2025
    Manufacturer
    MOTION COMPOSITES NY CORP.
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    501
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025, A USER EXPERIENCED A FALL WHILE TRANSFERRING IN OR OUT OF HER HELIO A7 WHEELCHAIR. DURING THE TRANSFER, THE ALUMINUM X-BRACE OF THE MOTION COMPOSITES HELIO A7 (B)(6) BROKE. THE CONCERNED WHEELCHAIR WAS MANUFACTURER ON JANUARY 6TH, 2021. THE REPORTER CONFIRMED THAT THE USER WAS HOSPITALIZED FOLLOWING THE FALL. MOTION COMPOSITES WAS INFORMED OF THE INCIDENT ON OCTOBER 3RD, 2025. FOLLOWING NOTIFICATION, MOTION COMPOSITES' CUSTOMER SERVICE TEAM ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES OF THE INCIDENT AND REQUESTED THAT THE INVOLVED PARTS BE RETURNED FOR EVALUATION. DESPITE MULTIPLE FOLLOW-UP ATTEMPTS, NO FURTHER DETAILS OR PICTURES WERE PROVIDED, AND THE PARTS WERE NOT RETURNED FOR ANALYSIS. REPLACEMENT PARTS WERE PROVIDED TO MOTION COMPOSITES' CLIENT. THIS INCIDENT IS BEING REPORTED OUT OF CAUTION. IT APPEARS TO BE AN ISOLATED CASE, AS NO OTHER INCIDENTS OR HOSPITALIZATION RELATED TO THE FAILURE OF THIS ALUMINUM X-BRACE HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2677550 MOTION COMPOSITES HELIO A7 WHEELCHAIR, MECHANICAL IOR MOTION COMPOSITES NY CORP. HELIO A7

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization