BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTDRIVE MX2

    MDR report key: 22177039 · Received June 10, 2025

    Report

    Report Number
    MW5171216
    Event Type
    Other
    Date Received
    June 10, 2025
    Date of Event
    April 5, 2025
    Report Date
    June 2, 2025
    Manufacturer
    MAX MOBILITY, LLC.
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE SMART DRIVE MX2 WOULD NOT RESPOND TO THE SHUT OFF COMMAND AND I CRASHED MY WHEELCHAIR. THE SMART DRIVE UNIT WAS DAMAGED, MY WHEELCHAIR WAS DAMAGED, AND I RECEIVED MANY BRUISES, CUTS AND SCRAPES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91048 SMARTDRIVE MX2 WHEELCHAIR, POWERED ITI MAX MOBILITY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other