BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3950109 · Received July 22, 2014

    Report

    Report Number
    1525712-2014-03867
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    June 12, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER DEALER CALLED IN AND STATED THAT THE LEFT HAND RIM IS SPLIT COMPLETELY IN HALF. DEALER STATES HE IS NOT AWARE OF WHAT MAY HAVE CAUSED THE ISSUE. DEALER STATED THERE WERE NO INJURIES PERTAINING TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428436 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET TA4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other