BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9XT SWINGAWAY FRAME STYLE 9153629153

    MDR report key: 4834656 · Received June 10, 2015

    Report

    Report Number
    9616091-2015-01546
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Report Date
    June 16, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RETURNED FOR EVALUATION. RETURNS EXPANDED EVALUATION REPORT STATES: UTILIZING EXISTING COMPLAINT INFORMATION, ACTUAL OBSERVATIONS, AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT IN ITS "AS RECEIVED" CONDITION, THE COMPLAINT WAS CONFIRMED FOR THE BENT HAND RIM. UNDERLYING CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE DEALER STATED THAT THE CHAIR WAS DAMAGED UPON RECEIPT ON THE ONE ARM DRIVE AND THE RIM IS BENT.

    Description of Event or Problem · 1

    PRODUCT WAS RETURNED FOR EVALUATION. RETURNS EXPANDED EVALUATION REPORT STATES: UTILIZING EXISTING COMPLAINT INFORMATION, ACTUAL OBSERVATIONS, AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT IN ITS "AS RECEIVED" CONDITION, THE COMPLAINT WAS CONFIRMED FOR THE BENT HAND RIM. UNDERLYING CAUSE COULD NOT BE DETERMINED. THE DEALER STATED THAT THE CHAIR WAS DAMAGED UPON RECEIPT ON THE ONE ARM DRIVE AND THE RIM IS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376367 9XT SWINGAWAY FRAME STYLE 9153629153 WHEELCHAIR, MECHANICAL IOR INVAMEX 9XT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other