BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIG BOUNDER

    MDR report key: 116753 · Received August 29, 1997

    Report

    Report Number
    2027797-1997-00001
    Event Type
    Injury
    Date Received
    August 29, 1997
    Date of Event
    May 1, 1997
    Report Date
    August 14, 1997
    Manufacturer
    21ST CENTURY SCIENTIFIC, INC.
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO INITIAL REPORTER, USER RECEIVED MULTIPLE LEG FRACTURES WHEN THE LEFT FRONT WHEEL OF HER POWER WHEELCHAIR CAME LOOSE, CAUSING HER TO FALL OUT OF THE WHEELCHAIR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization