BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2884427 · Received December 22, 2012

    Report

    Report Number
    1525712-2012-03221
    Event Type
    Malfunction
    Date Received
    December 22, 2012
    Report Date
    December 20, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 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. FRONT WELD AT CROSSBAR ON BOTH SIDE. PER DEALER, THE CONSUMER IS STILL USING THE CHAIR THOUGH THEY HAVE BEEN ADVISED NOT TO. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET CT6A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other