BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4689825 · Received April 14, 2015

    Report

    Report Number
    1525712-2015-02465
    Event Type
    Malfunction
    Date Received
    April 14, 2015
    Report Date
    April 3, 2015
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER STATES THAT THE BRACKET FOR THE ADJ ANGLE FOOTPLATE IS LOOSE AND WILL NOT HOLD TIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248593 SOLARA 3G DEMO 3 LOW SHEAR RECLINE/20 IN H MATRX PB BACK WHEELCHAIR, MECHANICAL IOR INVACARE TAYLOR STREET XTRA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other