BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9XT SWINGAWAY FRAME STYLE 9153629153

    MDR report key: 4964801 · Received August 4, 2015

    Report

    Report Number
    9616091-2015-01990
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Report Date
    July 13, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ADVISED CHAIR WOULD NOT TURN LEFT OR RIGHT EASILY INTERMITTENTLY. END USER ADVISED BOTH FORKS ARE BENT DUE TO SIDEWALKS. ENDUSER ADVISED CHAIR LEANS FORWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509328 9XT SWINGAWAY FRAME STYLE 9153629153 WHEELCHAIR, MECHANICAL IOR INVAMEX 9XDT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other