BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2880973 · Received December 20, 2012

    Report

    Report Number
    1525712-2012-03164
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    December 19, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER DEALER, THE TEETH ON THE ROUND HUBLOCK DISC ARE GROUND DOWN. LOOKS LIKE SOMEONE IS ENGAGING THE WEEK LOCKS WHILE DRIVING THE CHAIR. MDR FILED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other