BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 2000

    MDR report key: 3959909 · Received July 18, 2014

    Report

    Report Number
    1419652-2014-00185
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY COMPANY REPRESENTATIVE THAT CARERS WERE PREPARING TO REMOVE CLIENT FROM THE BATH AND LOWERED TUB ON TO THE ACTUATOR OF MOBILE HOISTS, WHICH CAUSED BATH FEET TO RAISE FROM FLOOR. WHEN HOIST FREED ITSELF, BATH FOOT PLATE CAUGHT CARERS LITTLE TOE. FROM THE INFO RECEIVED CAREGIVER CRUSHED MUSCLE TO LEFT FOOT LITTLE TOE AREA. X-RAY PROVED NO BROKEN BONES. MFR REF NUMBER 9611530-2014-00051.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423349 SYSTEM 2000 ILM ARJO HOSPITAL EQUIPMENT AB AR32201-GB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other