BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3181915 · Received June 21, 2013

    Report

    Report Number
    1525712-2013-04894
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 23, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE USER, THE WAY THE ARMS ARE POSITIONS IS CAUSING HIM TO HAVE CONSTANT BACK PAINS. MEDICAL INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 1

    CONSUMER STATED THE CHAIR ARMS ARE UNSTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282086 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET CRF

    Patients

    Seq Age Sex Outcome Treatment
    1 53 Required Intervention