BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABINA

    MDR report key: 1945904 · Received December 17, 2010

    Report

    Report Number
    8030916-2010-00059
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    April 14, 2010
    Report Date
    April 14, 2010
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS MDR IS PART OF A RETROSPECTIVE REVIEW IN ACCORDANCE WITH CAPA ACTIVITIES.

    Description of Event or Problem · 1

    FACILITY ALLEGES THAT A FEMALE PT'S FOOT WAS CUT WHEN THE SABINA FOOT TRAY THEY WERE STANDING ON CRACKED. PT STOOD ON THE FOOT TRAY. TRAY WAS OLD AND TRAY SUPPORT BROKE PINCHING AND CUTTING PT'S LITTLE TOE ON LEFT FOOT. PT WAS CLEANED AND BANDAGED. NEW TRAY WAS ORDERED, INSTALLED AND THE LIFT IS BACK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SABINA NON-AC POWERED PATIENT LIFT FSA LIKO AB SABINA COMFORT

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR