BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLARA 3G LTD 20W 12 COM 9153653248

    MDR report key: 5090494 · Received September 21, 2015

    Report

    Report Number
    1525712-2015-04582
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    August 21, 2015
    Report Date
    August 28, 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

    CLIENTS MOTHER PHONED TO REPORT THAT THE FLEX 3 BACKREST IS MISSING A BRACKET TO HOLD IT ONTO THE BACK FRAME. THE REA AZALEA IS THE SAME /SIMILAR TO THE SOLARA 3G WHICH IS MANUFACTURED AND/OR MARKETED BY INVACARE IN THE U.S. THIS ALLEGED INCIDENT OCCURRED IN THE (B)(6).

    Description of Event or Problem · 1

    CLIENTS MOTHER PHONED TO REPORT THAT THE FLEX 3 BACKREST IS MISSING A BRACKET TO HOLD IT ONTO THE BACK FRAME. THE REA AZALEA IS THE SAME /SIMILAR TO THE SOLARA 3G WHICH IS MANUFACTURED AND/OR MARKETED BY INVACARE IN THE U.S. THIS ALLEGED INCIDENT OCCURRED IN THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623761 SOLARA 3G LTD 20W 12 COM 9153653248 WHEELCHAIR, MECHANICAL IOR INVACARE TAYLOR STREET SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1