BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4240715 · Received November 10, 2014

    Report

    Report Number
    9616091-2014-02414
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 20, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CHAIR ARRIVED WITH A DAMAGED WHEEL. SHE STATES THE CUSTOMER CALLED HER AND STATES THE PART THAT THE WHEEL ATTACHES TO THAT IS WELDED WAS BROKEN. SHE STATES THERE WAS NO DAMAGE TO THE SHIPPING CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723649 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T422RDAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other