BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3140682 · Received May 31, 2013

    Report

    Report Number
    1525712-2013-04277
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Report Date
    February 20, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. INVACARE AWARENESS DATE (B)(4) 2013. COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FOR PROCESSING UNTIL (B)(4) 2013.

    Description of Event or Problem · 1

    PER PROVIDER THE SEAT FRAME IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241846 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET CT6A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other