BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2990500 · Received March 5, 2013

    Report

    Report Number
    1525712-2013-01625
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 6, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THE SCREW KEEPS COMING LOOSE ON THE ARM ASSEMBLY AND SEEMS TO BE STRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93933 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET T4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other