BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-Z BATH AND SHOWER SEAT WITH HANDLES

    MDR report key: 6052229 · Received October 24, 2016

    Report

    Report Number
    9681423-2016-00016
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    September 18, 2016
    Report Date
    October 24, 2016
    Manufacturer
    COMPASS HEALTH BRANDS
    Product Code
    ILS
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN NOT ANTICIPATED.

    Description of Event or Problem · 1

    THE CONSUMER HAS A SHOWER SEAT - THE POINT WHERE THE LEG MEETS THE SEAT IS CRACKED. WHEN THE HUSBAND OF THE END-USER PICKED UP THE SEAT, THE LEGS HAD FALLEN OUT. THE USER IS NOT REPORTED AS HAVING FALLEN/RECEIVED AN INJURY DUE TO THIS MALFUNCTION. THE SEAT IS REPORTED AS HAVING BEEN USED ON A FIBERGLASS SURFACE, AND IS REPORTED AS HAVING NOT BEEN SAT ON AT THE TIME THE EVENT HAD OCCURRED. ONE OF ITS FEET IS ALSO REPORTED AS HAVING A CUT IN IT. THE SHOWER SEAT IS OTHERWISE REPORTED AS HAVING BEEN OWNED, AND USED FOR 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702595 E-Z BATH AND SHOWER SEAT WITH HANDLES SHOWER SEAT ILS COMPASS HEALTH BRANDS FGB66000 0000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other