BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2990719 · Received March 5, 2013

    Report

    Report Number
    9616091-2013-00365
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 7, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    AN INVACARE REPRESENTATIVE REPORTED THAT THE FRONT STEM BEARINGS ARE NOISY. BAD BEARINGS ON THE FRONT OF THE WHEELCHAIR COULD CAUSE INSTABILITY IN THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94367 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other