BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3984352 · Received August 6, 2014

    Report

    Report Number
    9616091-2014-01427
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 24, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE PROVIDER STATES THAT THIS CHAIR IS USED IN A FACILITY AND THE FOOTPLATES WILL NOT STAY IN AN UP POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460711 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9TPZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other