BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9XT SWINGAWAY FRAME STYLE 9153629153

    MDR report key: 4886395 · Received July 2, 2015

    Report

    Report Number
    9616091-2015-01725
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Report Date
    June 5, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE BACK IS CAVING IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432209 9XT SWINGAWAY FRAME STYLE 9153629153 WHEELCHAIR, MECHANICAL IOR INVAMEX 9XDT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other