BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4753335 · Received May 6, 2015

    Report

    Report Number
    1525712-2015-02893
    Event Type
    Malfunction
    Date Received
    May 6, 2015
    Report Date
    April 8, 2015
    Manufacturer
    INVACARE REA AB
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AZALEA IS THE SAME /SIMILAR TO PRODUCTS WHICH ARE MANUFACTURED AND/OR MARKETED BY INVACARE IN THE U.S. THE ALLEGED INCIDENT OCCURRED IN THE (B)(6) ON A CHAIR THAT WAS SOLD IN EUROPE.

    Description of Event or Problem · 1

    ARMPAD FELL OFF THE ARMREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295902 SOLARA 3G DEMO 3 LOW SHEAR RECLINE/20 IN H MATRX PB BACK WHEELCHAIR, MECHANICAL IOR INVACARE REA AB REA_AZALEA_STOCK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other