BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3841532 · Received May 30, 2014

    Report

    Report Number
    9616091-2014-00969
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 17, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE PROVIDER STATES THERE IS A BROKEN SPOKE ON THE OUTER EDGE OF THE TIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318609 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9XDT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other