BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETAC HI-LOO TOILET ARM SUPPORT

    MDR report key: 3040615 · Received March 15, 2013

    Report

    Report Number
    3008986539-2013-00001
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    July 1, 2012
    Report Date
    September 11, 2012
    Manufacturer
    ETAC SUPPLY CENTER AB
    Product Code
    ILS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HI-LOO WC-ATTACHMENT CONSISTS OF TWO PARTS (TOP- AND BOTTOM HALF) WHICH ARE BONDED WITH EIGHT SCREWS. TWO OF THE SCREWS ON THE RIGHT SIDE IS MISSING AND THE THREADED HOLES (IN THE TOP HALF) FOR THESE SCREWS ARE DAMAGED. MARKS FROM THE SCREW HEADS SHOWS THAT THE SCREWS WERE FASTENED AT MANUFACTURING. WHERE THE SCREWS ARE MISSING THE TOP HALF HAS CRACKED WHEN LOAD WAS PUT ON THE RIGHT ARMREST. SINCE THE SCREWS WERE NOT RETURNED WITH THE MAIN PRODUCT, ETAC'S CONCLUSION IS THAT THE SCREWS WERE ALREADY MISSING WHEN THE TOP HALF BROKE. IT HAS NOT BEEN POSSIBLE TO ESTABLISH WHY THE SCREWS ARE MISSING AND WHY THE THREADS ARE DAMAGED.

    Description of Event or Problem · 1

    WHEN VISITING THE USER THE HOME CARE STAFF NOTICED THAT THE RIGHT ARMREST OF THE HI-LOO TILTED DOWNWARDS AND THE TOP HALF OF THE HI-LOO WC-ATTACHMENT WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110228 ETAC HI-LOO TOILET ARM SUPPORT ADAPTER, HYGIENE ILS ILS ETAC SUPPLY CENTER AB 80301116

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR