BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDCONTROL DIAL UTILIZED WITH SMARTDRIVE MX2+ POWER ASSIST DEVICE

    MDR report key: 22816449 · Received August 15, 2025

    Report

    Report Number
    MW5174628
    Event Type
    Injury
    Date Received
    August 15, 2025
    Date of Event
    July 21, 2024
    Manufacturer
    MAX MOBILITY, LLC
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DESPITE MY PERMOBILE SPEED DIAL BEING IN THE OFF POSITION, MY MOTOR CONTINUED OPERATING AND PROPELLED ME INTO FOUR LANES OF ONCOMING TRAFFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763018 SPEEDCONTROL DIAL UTILIZED WITH SMARTDRIVE MX2+ POWER ASSIST DEVICE WHEELCHAIR, POWERED ITI MAX MOBILITY, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Life Threatening