BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9XT SWINGAWAY FRAME STYLE 9153629153

    MDR report key: 4991260 · Received August 11, 2015

    Report

    Report Number
    9616091-2015-02040
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Report Date
    July 20, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    END USER IS STATING THAT THE RIGHT SIDE CROSSBRACE IS BROKEN ABOUT 3 INCHES ABOUT THE MIDDLE WHERE IS CROSSES THE RIGHT SIDE. END USER IS STATING IT IS A CLEAN BRAKE. END USER STATES WHEN HE WAS FOLDING THE CHAIR IT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524072 9XT SWINGAWAY FRAME STYLE 9153629153 WHEELCHAIR, MECHANICAL IOR INVAMEX 9XT-PTO-33417

    Patients

    Seq Age Sex Outcome Treatment
    1 Other