BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3935721 · Received July 15, 2014

    Report

    Report Number
    1525712-2014-03696
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    April 30, 2014
    Report Date
    June 10, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PATIENT¿S FATHER STATED HIS SON HAS FALLEN OUT OF CHAIR 3 TIMES. MOSTLY BECAUSE OF BRAKES ALSO BECAUSE THE ORIGINAL FRONT RIGGINGS HAVE BEEN REMOVED AS THEY NEED TO BE REPAIRED. THEY WILL NOT LOCK INTO THE FRAME THE RIGHT IS MORE WORN THAN THE LEFT. PATIENT FELL IN THE KITCHEN, WAS STRANDED BUT NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412548 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET TA4

    Patients

    Seq Age Sex Outcome Treatment
    1 27 Other