BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3914048 · Received July 3, 2014

    Report

    Report Number
    9616091-2014-01146
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 2, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW BACKED OUT AND CAUSED LEFT WHEEL LOCK TO BREAK ON THE SOLARA3G WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391767 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other