BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3200598 · Received July 1, 2013

    Report

    Report Number
    1525712-2013-05243
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 5, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES THE CHAIR WAS RETURNED TO IVC (B)(4) WITH A BROKEN GUSSET FOR THE FIXED BACK. TOP END IS REPLACING THE FRAME UNDER WARRANTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298493 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET TEDTI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other