BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARISA

    MDR report key: 4143526 · Received August 13, 2014

    Report

    Report Number
    1419652-2014-00198
    Event Type
    Injury
    Date Received
    August 13, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT DURING THE RESIDENT'S TRANSFER FROM THE TOILET TO THE BED USING MARISA PASSIVE LIFT, THE LEG CLIP DETACHED FROM THE HANGER BAR OF THE LIFT AND THE RESIDENT FELL STRIKING HER HEAD ON THE LIFT LEG. IN ACCORDANCE TO INFORMATION PROVIDED THE RESIDENT RECEIVED SCALP LACERATION, SUBARACHNOID HEMORRHAGE TO THE HEAD AS A CONSEQUENCE OF THE EVENT AND WAS THEN SENT TO EMERGENCY ROOM FOR CT SCAN, XRAY AND WOUND CLOSURE. MFR REF# 9611530-2014-00057.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483106 MARISA FSA ARJO MED AB LTD KGA0200

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention