BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4094028 · Received September 16, 2014

    Report

    Report Number
    9616091-2014-01879
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 21, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES RIGHT SIDE OF FRAME WHERE THE BACK CANE MEETS THE BOTTOM MOST HORIZONTAL BAR., THE WELD IS BROKEN. DEALER NOTICED WHEN CHANGING THE CUSTOMER'S WHEEL. DEALER STATES THE WELD IS NO LONGER ATTACHED TO THE FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573154 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T4X24RDA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other