BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARA 3000

    MDR report key: 594195 · Received April 20, 2005

    Report

    Report Number
    3004468271-2005-00001
    Event Type
    Injury
    Date Received
    April 20, 2005
    Date of Event
    April 8, 2005
    Report Date
    April 19, 2005
    Manufacturer
    MEDIBO N.V.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GNA WAS REMOVING THE PATIENT FROM THE TOILET. AS SHE WAS TRYING TO LIFT THE PATIENT, THE PATIENT BECAME HESITANT AND DID NOT WANT TO BE LIFTED. THE PATIENT THEN GRABBED THE TOILET HAND RAILS WHILE THE GNA WAS ATTEMPTING TO RAISE THE LIFT. THE PATIENT THEN SLID OUT OF THE LIFTING BELT, HITTING THE BACK OF HEAD ON THE GROUND. THE PATIENT SUFFERED A 1-1/2 INCH CUT ON THE BACK OF HEAD, WHICH REQUIRED THREE STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA 3000 PATIENT LIFT FSA MEDIBO N.V. HEAXXXX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention