BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3103517 · Received May 9, 2013

    Report

    Report Number
    9616091-2013-00784
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 15, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH THE RUBBER COMING OFF THE WHEEL ON A 9SL MANUAL WHEELCHAIR. THIS EVENT COULD CAUSE POSSIBLE PRODUCT INSTABILITY AND THE POTENTIAL FOR NOT PERMITTING THE USER TO PROPERLY NAVIGATE THE WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203418 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9SL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other