BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 5925647 · Received September 2, 2016

    Report

    Report Number
    9681423-2016-00009
    Event Type
    Malfunction
    Date Received
    September 2, 2016
    Date of Event
    August 15, 2016
    Report Date
    October 10, 2016
    Manufacturer
    N/A
    Product Code
    ILS
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS RETURNED TO MANUFACTURER, AND INSPECTED ON 9/15/2016.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT HER CHAIR IS RUSTING AND ONE OF THE LEGS BROKE OFF. THE DEVICE IS REPORTED AS BEING USED IN AN END-USER'S HOME ON A FIBERGLASS SURFACE. ALL FOUR LEGS/LEG TIPS ARE REPORTED AS TOUCHING THE FLOOR AT THE TIME THE INCIDENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576259 N/A N/A ILS N/A N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other