BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4041060 · Received August 27, 2014

    Report

    Report Number
    1525712-2014-05148
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 13, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER STATES THAT THE PATIENT WAS AT HOME IN HIS RESTROOM WHEN THE CAMBER SLEEVE CAM OUT, THE WHEEL FELL OFF AND THE PATIENT WENT TO THE FLOOR. THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521450 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET CT7A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other