BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTDRIVE

    MDR report key: 17691991 · Received September 5, 2023

    Report

    Report Number
    MW5145213
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    June 18, 2023
    Report Date
    August 30, 2023
    Manufacturer
    MAX MOBILITY, LLC
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS TRAVELING IN MY WHEELCHAIR WITH MY SMARTDRIVE. I HIT SOMETHING ON THE SIDEWALK AND THE CHAIR VEERED TO THE RIGHT, I TRIED TO STOP THE CHAIR AND IT DID NOT RESPOND. I TRIED TO STOP THE CHAIR AGAIN AND IT DID NOT RESPOND. I COULD NOT HOLD THE CHAIR AND IT ROLL OFF THE SIDEWALK INTO THE STREET. A BUS HAPPENED TO BE PASSING BY AND I RAN INTO THE SIDE OF IT. I BROKE TWO BONES IN ONE LEG AND ONE IN THE OTHER. HAD TO GO THE HOSPITAL. PERMOBILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120867 SMARTDRIVE WHEELCHAIR, POWERED ITI MAX MOBILITY, LLC MX2+

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Disability| H AMLODIPINE 10MG.| ATORVASTATIN 20MG.| CARVEDILOL 6.25MG.| GABAPENTIN 800 MG.| IRBESARTAN 300 12.5MG.| ONE A DAY VITAMINS.