BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3781059 · Received April 30, 2014

    Report

    Report Number
    9616091-2014-00786
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 26, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE PROVIDER CALLED IN TO STATE AN INCIDENT OCCURRED WHEN AN END USER WAS ATTEMPTING TO LEAVE HIS SHOP. HE IS A DOUBLE AMPUTEE AND AS ATTEMPTING TO HOLD THE DOOR WITH ONE HAND AND THE WHEEL OF THE CHAIR WITH THE OTHER WHILE CROSSING THE THRESHOLD, THE CHAIR REARED BACK AND CAUSED THE END USER TO FALL. AT THAT TIME, NO COMPLAINTS OF PAIN. DEALER STATES THAT AT A LATER DATE, THE VETERAN STATED HE BROKE HIS TAILBONE WHEN LEAVING THE BUILDING. THE END USER ALLEGED WENT TO THE EMERGENCY ROOM THE DAY AFTER THE INCIDENT AND X-RAYS CONFIRMED THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259773 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other