BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3932486 · Received July 14, 2014

    Report

    Report Number
    9616091-2014-01194
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    May 13, 2014
    Report Date
    June 6, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE LEFT BRAKE (FOOT OPERATED WHEELLOCK ASSEMBLY) ON A SOLARA3G WHEELCHAIR WILL NOT STAY IN ADJUSTMENT. IT HAS TO BE ADJUSTED EVERY WEEK OR SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411117 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other