BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9XT SWINGAWAY FRAME STYLE 9153629153

    MDR report key: 5070186 · Received September 11, 2015

    Report

    Report Number
    9616091-2015-02235
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Report Date
    August 13, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP WILL BE SENT IF THE PRODUCT OR ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE DEALER STATED THE WHEELCHAIR HAD RUSTED AND HAS A LOT OF CORROSION. THE SEAT UPHOLSTERY'S RIPPED, CROSSBRACE IS BROKEN FROM THE RIGHT TOP WHERE THE STABILIZER ATTACHES, WHEEL LOCKS ARE WORN OUT, AND THE FORK STEMS ARE RUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603501 9XT SWINGAWAY FRAME STYLE 9153629153 WHEELCHAIR, MECHANICAL IOR INVAMEX 9XT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other