BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMALL UNIVERSAL QUILTED SLING

    MDR report key: 3610898 · Received January 20, 2014

    Report

    Report Number
    3007802293-2014-00002
    Event Type
    Death
    Date Received
    January 20, 2014
    Date of Event
    January 16, 2013
    Report Date
    January 20, 2014
    Manufacturer
    PRISM MEDICAL SERVICES USA
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CARE AID WAS TRANSFERRING A CLIENT USING A WAVERLEY GLEN SMALL UNIVERSAL QUILTED SLING ON A BHM LIFT. WHEN THE CLIENT WAS LIFTED SHE FELL FROM THE SLING, BREAKING BOTH HER LEGS AND RESULTING IN HER DEATH. THE CARE AID HOOKED UP THE SLING INCORRECTLY AND WAS ALSO USING THE LIFT AGAINST THE SITE'S POLICY OF TWO PEOPLE TO COMPLETE A TRANSFER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46374 SMALL UNIVERSAL QUILTED SLING UNIVERSAL QUILTED SLING FSA PRISM MEDICAL SERVICES USA 537310

    Patients

    Seq Age Sex Outcome Treatment
    1 Death