BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-Z BATH AND SHOWER SEAT WITH HANDLES

    MDR report key: 5950986 · Received September 14, 2016

    Report

    Report Number
    9681423-2016-00014
    Event Type
    Malfunction
    Date Received
    September 14, 2016
    Date of Event
    August 22, 2016
    Report Date
    October 11, 2016
    Manufacturer
    N/A
    Product Code
    ILS
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER WAS TAKING A SHOWER, AND THE LEGS ON THE SHOWER SEAT BUCKLED, CAUSING IT TO TIP OVER. THE END-USER WAS NOT INJURED. THE DEVICE IS REPORTED AS HAVING BEEN USED ON A CERAMIC SURFACE, WITH ALL FOUR LEGS TOUCHING THE FLOOR AT THE TIME THE INCIDENT HAD OCCURRED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, (B)(4), ON 9/9/2016. THE ORIGINAL ITEM NUMBER PROVIDED IN THE INITIAL COMPLAINT WAS FGB67100 0000, UNIVERSAL BATH BENCH W/BACK. THE ITEM NUMBER OF THE RETURNED DEVICE WAS FGB66000 0000 E-Z BATH & SHOWER SEAT WITH HANDLES. THE MALFUNCTION REPORTED BY THE CUSTOMER/END-USER IN THE INITIAL COMPLAINT WAS THAT THE FGB67100 0000'S LEGS HAD BUCKLED, CAUSING THE DEVICE TO TIP OVER. THE RETURNED FGB66000 0000 WAS FOUND TO HAVE ITS FRONT SLOT WHERE IT LEG SLIDES INTO PLACE AS CRACKED - THIS ALLOWED THE LEG TO SLIGHTLY MOVE, AND COMPROMISE ITS INTEGRITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602760 E-Z BATH AND SHOWER SEAT WITH HANDLES BATH AND SHOWER SEAT ILS N/A FGB66000 0000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other