BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLARA 3G LTD 20W 24 COM 9153653250

    MDR report key: 5242931 · Received November 23, 2015

    Report

    Report Number
    1525712-2015-05294
    Event Type
    Malfunction
    Date Received
    November 23, 2015
    Report Date
    November 3, 2015
    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

    REPAIR TECHNICIAN OBSERVED DEFECTIVE WELD ON FRAME AT BRACKET WHERE BACKREST RECLINE MECHANISM ATTACHED. 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

    REPAIR TECHNICIAN OBSERVED DEFECTIVE WELD ON FRAME AT BRACKET WHERE BACKREST RECLINE MECHANISM ATTACHED. 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
    772871 SOLARA 3G LTD 20W 24 COM 9153653250 WHEELCHAIR, MECHANICAL IOR INVACARE TAYLOR STREET SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1