BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4965776 · Received August 4, 2015

    Report

    Report Number
    1525712-2015-04165
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Report Date
    July 14, 2015
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP WILL BE SENT IF THE PRODUCT OR ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    DEALER STATES THE CUSTOMER WAS GETTING OUT OF HER VAN AND THE CHAIR COLLAPSED. NO REPORTS OF INJURY. DEALER STATES THE PIVOT LINKS ARE WHAT CAUSED IT AS THEY ARE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510238 SOLARA 3G DEMO 3 LOW SHEAR RECLINE/20 IN H MATRX PB BACK WHEELCHAIR, MECHANICAL IOR INVACARE TAYLOR STREET MVPF80

    Patients

    Seq Age Sex Outcome Treatment
    1 Other