BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9XT SWINGAWAY FRAME STYLE 9153629153

    MDR report key: 5086966 · Received September 18, 2015

    Report

    Report Number
    9616091-2015-02259
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Report Date
    September 11, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - 09/14/2015 - SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    END USER STATES THAT THE SHAFT THAT HOLDS THE CASTER ON FELL OUT OF THE FRAME AND HE FELL AND SKINNED HIS NOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620336 9XT SWINGAWAY FRAME STYLE 9153629153 WHEELCHAIR, MECHANICAL IOR INVAMEX 9SL

    Patients

    Seq Age Sex Outcome Treatment
    1