BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3071930 · Received April 22, 2013

    Report

    Report Number
    9616091-2013-00677
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 27, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USERS' HUSBAND ALLEGES THAT THE BRAKE WAS BEING LOCKED AND NOTICED THAT THE BOLT HAD BROKEN (BELIEVES BROKEN WHEN RELEASED THE BRAKE) ON THE RIGHT SIDE...CURRENTLY PART OF THE BOLT IS STILL STUCK IN THE CHAIR AND UNABLE TO GET OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172912 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9SL

    Patients

    Seq Age Sex Outcome Treatment
    1 75 Other