BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLARA 3G DEMO 3 LOW SHEAR RECLINE/20 IN H MATRX PB BACK

    MDR report key: 4899179 · Received July 8, 2015

    Report

    Report Number
    1525712-2015-03778
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Report Date
    June 12, 2015
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    DEALER STATES USER IS MISSING SOME OF THE ATTACHMENT POINTS FOR HIS HANDRIMS, AND THE URETHANE TIRES ARE "CHEWED UP". HE SAID HE HAS NO IDEA HOW THAT HAPPENED. HE ALSO STATES THE WHEEL LOCKS SEEM TO BE MADE OF REALLY PLIABLE METAL. THE DEALER ALREADY HAS A QUOTE FOR THIS ON QT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443315 SOLARA 3G DEMO 3 LOW SHEAR RECLINE/20 IN H MATRX PB BACK WHEELCHAIR, MECHANICAL IOR INVACARE TAYLOR STREET SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other