BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4043597 · Received August 28, 2014

    Report

    Report Number
    1525712-2014-05169
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 29, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER LEANED BACK ONE DAY AND THE RIGHT SIDE BACK CANE POPPED ON THE XTRA WHEELCHAIR. DEALER STATED HE BELIEVES THE ISSUE STEMS FROM NORMAL WEAR AND TEAR. DEALER STATED THERE WERE NO INJURIES ASSOCIATED WITH THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525852 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET XTRA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other