BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3910086 · Received July 2, 2014

    Report

    Report Number
    1525712-2014-03334
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Report Date
    May 30, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    ALL NUTS AND BOLTS, NO EXCEPTIONS, AND ARM REST TUBING ARE RUSTED. ASKED CUSTOMER IF CHAIR HAD BEEN STORED IN AN AREA WITH HIGH HUMIDITY LEVELS, CLIENT RESPONDED NEGATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386908 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET PATRIOT

    Patients

    Seq Age Sex Outcome Treatment
    1 60 Other