BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4002367 · Received August 12, 2014

    Report

    Report Number
    9616091-2014-01484
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Report Date
    July 10, 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 DEALER STATES THAT THE END USER REPORTS THE WHOLE RIGHT ARM BEING LOOSE AND WOBBLY CAUSING THE RIGHT ARM PAD TO CRACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480472 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TREX20RFP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other