BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLARA 3G LTD 20W 24 COM 9153653250

    MDR report key: 5655775 · Received May 16, 2016

    Report

    Report Number
    1525712-2016-01566
    Event Type
    Malfunction
    Date Received
    May 16, 2016
    Report Date
    May 11, 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

    THE SEAT FRAME WAS FRACTURED AT THE POINT OF ATTACHMENT WITH THE TILT 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 THE (B)(6).

    Description of Event or Problem · 1

    THE SEAT FRAME WAS FRACTURED AT THE POINT OF ATTACHMENT WITH THE TILT 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 THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311700 SOLARA 3G LTD 20W 24 COM 9153653250 WHEELCHAIR, MECHANICAL IOR INVACARE TAYLOR STREET UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1