BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR SYSTEM

    MDR report key: 15660278 · Received October 24, 2022

    Report

    Report Number
    9615350-2022-00008
    Event Type
    Injury
    Date Received
    October 24, 2022
    Date of Event
    December 10, 2021
    Report Date
    October 24, 2022
    Manufacturer
    MOTION CONCEPTS LP
    Product Code
    ITI
    UDI-DI
    00754014710065
    PMA / PMN Number
    K150574
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MENTIONED SYSTEM WAS SHIPPED FROM MOTION CONCEPTS TO MEDBLOC (MOTION CONCEPTS USA IMPORTER/DISTRIBUTOR), AS PER DEALER REQUIREMENTS, ON 07-APR-2020 AND THEN WAS SOLD TO NUMOTION-BALTIMORE, MD ON 08-APR-2020. THE CAUSE OF THE INCIDENT IS NOT BECAUSE OF ANY SYSTEM MALFUNCTION. HOWEVER, AN INJURY HAS BEEN INVOLVED IN THIS INCIDENT. THEREFORE, WE CONSIDER IT AS REPORTABLE EVENT.

    Description of Event or Problem · 0

    ON 23-SEP-2022, MOTION CONCEPTS LP WAS NOTIFIED BY MEDBLOC INC. (MOTION CONCEPTS IMPORTER), THAT ONE OF THEIR DEALERS (NUMOTION - BALTIMORE, MD) INFORMED THEM OF AN INCIDENT THAT TOOK PLACE ON (B)(6) 2021. THE DEALER REPORTED THAT THE END USER WAS WAITING ON THE SIDEWALK, WHEN A VEHICLE CAME ACCROSS THE SIDEWALK AND STRUCK THE FRONT OF HER WHEELCHAIR. THIS CAUSED HER TO BE DRAGGED 1 TO 2 FEET. THE FRONT LEFT WHEEL OF THE WHEELCHAIR IS BROKEN OFF. THE END USER HAS A BRUISE ON HER LEFT LEG AS A CONCESQUENCE OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2146780 POWERED WHEELCHAIR SYSTEM WHEELCHAIR ITI MOTION CONCEPTS LP 45T-12L-RESR-MAXX 00754014710065

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other