BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART DRIVE

    MDR report key: 22161835 · Received June 6, 2025

    Report

    Report Number
    MW5171170
    Event Type
    Injury
    Date Received
    June 6, 2025
    Date of Event
    August 5, 2024
    Report Date
    May 30, 2025
    Manufacturer
    PERMOBIL / PERMOBIL, INC.
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY SMARTDRIVE TURNED ON BY ITSELF AND RAN ME INTO A METAL BAR. I STILL HAVE A BRUISE, 9 MONTHS LATER. IT MAY BE PERMANENT DISCOLORATION. THANKFULLY I DID NOT GO INTO THE LAKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654901 SMART DRIVE WHEELCHAIR, POWERED ITI PERMOBIL / PERMOBIL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other