BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2771432 · Received October 4, 2012

    Report

    Report Number
    1525712-2012-01724
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    October 2, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MODEL SOLARE 3G SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY ONE MONTH OLD. THE OWNER'S MANUAL PART NUMBER 1154295, REV.C(DEC-10), WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM.

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE HAS REPORTED AN EVENT OF THE STROLLER HANDLE "KNUCKLE" INEXPLICABLY BROKE OFF. NO INJURY REPORTED. OCCURRED DURING AN IN-SERVICE IN A USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET SOLARA 3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other