BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROLLATOR 9153651315

    MDR report key: 6105367 · Received November 16, 2016

    Report

    Report Number
    1525712-2016-02744
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    October 17, 2016
    Report Date
    November 3, 2016
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    "THE PATIENT WAS OUT WALKING WHEN THE PLASTIC FRONT FORK TO THE RIGHT WHEEL BROKE AND FELL OFF. NO HARM. MATERIAL FATIGUE. THE WARRANTY ON THE WALKER WENT OUT 16-04-25". THE FUTURA IS THE SAME /SIMILAR TO ALL INVACARE ROLLATORS WHICH ARE, OR HAVE BEEN MANUFACTURED AND/OR MARKETED BY INVACARE IN U.S. THE ALLEGED INCIDENT OCCURRED IN, (B)(6).

    Description of Event or Problem · 1

    "THE PATIENT WAS OUT WALKING WHEN THE PLASTIC FRONT FORK TO THE RIGHT WHEEL BROKE AND FELL OFF. NO HARM. MATERIAL FATIGUE. THE WARRANTY ON THE WALKER WENT OUT 16-04-25". THE FUTURA IS THE SAME /SIMILAR TO ALL INVACARE ROLLATORS WHICH ARE, OR HAVE BEEN MANUFACTURED AND/OR MARKETED BY INVACARE IN U.S. THE ALLEGED INCIDENT OCCURRED IN, (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758240 ROLLATOR 9153651315 WALKER, MECHANICAL IKX INVACARE TAYLOR STREET UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1