BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4211475 · Received October 29, 2014

    Report

    Report Number
    9616091-2014-02280
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 9, 2014
    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

    THE TBM (B)(6) CALLED IN AND STATES THAT THE LEFT PIVOT TUBE IS PUNCHED INCORRECTLY MAKING THE FOOTPLATE SIT MORE FORWARD THEN THE OTHER SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694072 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other