BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARA 300

    MDR report key: 3080787 · Received April 19, 2013

    Report

    Report Number
    1419652-2013-00103
    Event Type
    Injury
    Date Received
    April 19, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z.O.O.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE COMPANY REP DESCRIPTION: PT HAD BEEN LIFTED WITH THE SARA 3000. AFTER THAT SHE HAD COMPLICATIONS, PAIN IN SHOULDER AND BREAST. IT APPEARED THAT SHE HAD BRUISES AT SHOULDERS AND BREAST. SHE WAS BROUGHT OVER TO THE HOSPITAL AND IT WAS DISCOVERED THAT A MUSCLE HAS COME LOOSE OFF HER STERNUM. CUSTOMER COULD ONLY COMBINE THE EVENT WITH THE LIFTING IN THE SARA 3000 AND ASKED FOR ADVICE. PLEASE REFERENCE MFR REPORT #3007420694-2013-00019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170443 SARA 300 ACTIVE FLOOR LIFTS FSA ARJOHUNTLEIGH POLSKA SP. Z.O.O. HEA0002

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention