BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4111052 · Received September 23, 2014

    Report

    Report Number
    9616091-2014-01953
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY THE DEALER THAT THE PART DOWN BY THE FOOTPLATE OF AN ELEVATING LEGREST ON A TREX28R WHEELCHAIR IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591547 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TREX28R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other