BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOUNDER

    MDR report key: 8087115 · Received November 19, 2018

    Report

    Report Number
    2027797-2018-00001
    Event Type
    Injury
    Date Received
    November 19, 2018
    Date of Event
    May 16, 2017
    Report Date
    October 16, 2018
    Manufacturer
    21ST CENTURY SCIENTIFIC, INC
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    WE INITIALLY DETERMINED THAT THIS WAS NOT A REPORTABLE EVENT DUE TO THE NATURE OF THE INJURY AND AGE OF THE DEVICE, BUT AFTER AN FDA AUDIT IT WAS DETERMINED THAT IT PROBABLY SHOULD HAVE BEEN REPORTED. WE HAVE UPDATED OUR INTERNAL PROCEDURES TO HELP WITH THE DETERMINATION OF REPORTABLE EVENTS IN THE FUTURE TO ENSURE THEY ARE REPORTED WITHIN THE TIME REQUIRED.

    Description of Event or Problem · 1

    USER WAS DRIVING HER WHEELCHAIR WHEN IT CAME TO A STOP VEERED TO ONE SIDE AND SHE FELL OUT OF THE CHAIR BREAKING HER ARM. THE USER WAS NOT WEARING HER SEAT BELT. HAD SHE BEEN WEARING A SEAT BELT, SHE WOULD NOT HAVE FALLEN OUT OF THE CHAIR WHEN IT CAME TO A STOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922748 BOUNDER POWER WHEELCHAIR ITI 21ST CENTURY SCIENTIFIC, INC BOUNDER

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R