BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNO

    MDR report key: 1946003 · Received December 17, 2010

    Report

    Report Number
    8030916-2010-00074
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    May 5, 2010
    Report Date
    May 21, 2010
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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

    THE PT WAS BEING TRANSFERRED FROM BED TO WHEELCHAIR BY CAREGIVER. THE PT ALMOST FELL OUT OF THE SLING WHEN THE SLING LOOP BECAME DETACHED FROM THE SLING BAR. NO INJURY WAS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNO NON-AC POWERED PATIENT LIFT FSA LIKO AB UNO 102EE

    Patients

    Seq Age Sex Outcome Treatment
    1