BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLARA 3G LTD 20W 24 COM 9153653250

    MDR report key: 5656479 · Received May 16, 2016

    Report

    Report Number
    1525712-2016-01610
    Event Type
    Malfunction
    Date Received
    May 16, 2016
    Report Date
    May 12, 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

    SEAT FRAME FRACTURED AT THE POINT OF ATTACHMENT WITH RECLINE ACTUATOR. 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

    SEAT FRAME FRACTURED AT THE POINT OF ATTACHMENT WITH RECLINE ACTUATOR. 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
    311108 SOLARA 3G LTD 20W 24 COM 9153653250 WHEELCHAIR, MECHANICAL IOR INVACARE TAYLOR STREET SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1