BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4192313 · Received October 22, 2014

    Report

    Report Number
    9616091-2014-02216
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Report Date
    October 1, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES THAT THE RIGHT CROSSBRACE BROKE AT THE WELD WHICH CAUSED THE LEFT CROSSBRACE TO BEND AND THE PIVOT LINKS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673571 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9XT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other