BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5778542 · Received July 8, 2016

    Report

    Report Number
    1525712-2016-02440
    Event Type
    Malfunction
    Date Received
    July 8, 2016
    Report Date
    July 4, 2016
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OF THE SEAT FRAME SUPPORT PLATES HAS FRACTURED AT THE POINT WHERE IT WAS WELDED TO THE SEAT FRAME (UNDER THE SEAT). THE REA AZALEA IS THE SAME /SIMILAR TO THE SOLARA 3G WHICH IS MANUFACTURED AND/OR MARKETED BY INVACARE IN THE U.S. THE ALLEGED INCIDENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ONE OF THE SEAT FRAME SUPPORT PLATES HAS FRACTURED AT THE POINT WHERE IT WAS WELDED TO THE SEAT FRAME (UNDER THE SEAT) . THE REA AZALEA IS THE SAME /SIMILAR TO THE SOLARA 3G WHICH IS MANUFACTURED AND/OR MARKETED BY INVACARE IN THE U.S. THE ALLEGED INCIDENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433595 SOLARA 3G DEMO 3 LOW SHEAR RECLINE/20 IN H MATRX PB BACK WHEELCHAIR, MECHANICAL IOR INVACARE TAYLOR STREET UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1