BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLARA 3 G LTD 16 W 12 COM 9153653246

    MDR report key: 4821809 · Received June 5, 2015

    Report

    Report Number
    9616091-2015-01524
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Report Date
    May 12, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP WILL BE FILED IF ADDITIONAL INFORMATION IS ACQUIRED.

    Description of Event or Problem · 1

    PROVIDER STATES THAT THE TWO BALL BEARINGS AT THE TIP OF THE QUICK RELEASE AXLE HAVE COME APART THERE THE QUICK RELEASE AXLE NO LONGER WORKS. NO ADDITIONAL INFORMATION PROVIDED. PROTOCOL QUESTIONS DO NOT APPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366040 SOLARA 3 G LTD 16 W 12 COM 9153653246 WHEELCHAIR, MECHANICAL IOR INVAMEX SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other