BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HELIO A6

    MDR report key: 21297679 · Received January 31, 2025

    Report

    Report Number
    MW5165563
    Event Type
    Injury
    Date Received
    January 31, 2025
    Date of Event
    January 13, 2025
    Report Date
    January 27, 2025
    Manufacturer
    MOTION COMPOSITES
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HELIOS A6 BY MOTION COMPOSITES WHEELCHAIR BROKEN BRAKE INCIDENT CAUSED ELDER TO FALL FROM STANDING TO FLOOR WHILE ATTEMPTING TO TRANSFER INTO WHEELCHAIR RESULTING IN FEMUR FRACTURE, HOSPITALIZATION ETC. I BELIEVE THE CHAIR IS 3 YEARS OLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245114 HELIO A6 WHEELCHAIR, MECHANICAL IOR MOTION COMPOSITES

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Hospitalization| S ASPIRIN.| ELIQUIS.| LAMITROGINE.| LEVOTHYROXINE.| METOPROLOL.| OZEMPIC.| TRAZODONE.