BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALENTI

    MDR report key: 3689694 · Received March 6, 2014

    Report

    Report Number
    1419652-2014-00065
    Event Type
    Injury
    Date Received
    March 6, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 5, 2014
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z.O.O.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT THE CAREGIVER WAS DRYING RESIDENT IN ALENTI AFTER BATH AND APPLYING CLOTHING. THE CAREGIVER WAS BEHIND LIFT ON LEFT SIDE. ALENTI TIPPED OVER AND FELL BUT NOT ON RESIDENT, RESIDENT FELL ON FLOOR AND LANDED ON HER KNEES AND ROLLED TO LEFT SIDE. RESIDENT WAS LEANING FORWARD AGAINST ARM, CAREGIVER THOUGHT RESIDENT WAS TRYING TO HAVE A BOWEL MOVEMENT. THERE WAS ONLY ONE CAREGIVER IN ROOM DURING THE INCIDENT. WHEN INCIDENT OCCURRED CAREGIVER ALERTED COLLEAGUES THEY ARRIVED TO ASSIST. STAFF WERE UNSURE IF SEAT BELT WAS USED. REF MFR# 3007420694-2014-00022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134230 ALENTI FSA ARJOHUNTLEIGH POLSKA SP. Z.O.O. CDB8053-01

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization