BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOUNDER

    MDR report key: 440370 · Received January 28, 2003

    Report

    Report Number
    2027797-2003-00001
    Event Type
    Injury
    Date Received
    January 28, 2003
    Report Date
    January 21, 2003
    Manufacturer
    21ST CENTURY SCIENTIFIC, INC.
    Product Code
    ITI
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHILE TILTING BACK THE CHAIR, TILT ACTUATOR BROKE AND CHAIR SEAT TILTED BACK TOO FAR. USER CLAIMS THEIR HEAD IMPACTED SOMETHING. BUT INJURIES HAVE NOT BEEN COMPLETELY DIAGNOSED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other