BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSFER BENCH

    MDR report key: 4107099 · Received September 5, 2014

    Report

    Report Number
    1417592-2014-00080
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    July 31, 2014
    Report Date
    August 27, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    ILS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE SITTING ON THE BENCH AND TRANSFERRING INTO THE TUB, IT WAS REPORTED THAT ONE OF THE SUCTION CUPS RIPPED AND THE END USER FELL ONTO A TILE FLOOR. HE SUFFERED A RIGHT LEG FRACTURE WHICH WAS IMMOBILISED WITH A BRACE. HE WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND SUBSEQUENTLY DISCHARGED WITH PHYSICAL THERAPY AND A DIAGNOSIS OF ACUTE GAIT DYSFUNCTION. THE SAMPLE WAS RETURNED AND EVALUATED. ALL FOUR LEGS WERE INTACT AND NO LEG DEFORMITIES WERE NOTED. ONE OF THE TWO SUCTION CUPS WAS FOUND TO BE RIPPED. THE CAUSE OF THE TEAR TO THE SUCTION CUP WAS NOT DETERMINED. WE CANNOT RULE OUT THE POSSIBILITY THE TEAR WAS CAUSED BY THE DEVICE BEING LIFTED OR MOVED WHILE THE SUCTION WAS ENGAGED AND WITHOUT FIRST RELEASING THE SUCTION TO THE TUB FLOOR. NO MANUFACTURING DEFECT WAS IDENTIFIED DURING THE SAMPLE EVALUATION. IT IS NOT CLEAR HOW THE TORN SUCTION CUP COULD HAVE CAUSED THE END USER TO FALL AS THE LEGS WERE INTACT, THE DEVICE WAS STABLE AND AT THE SAME TIME WAS ABLE TO SUPPORT THE WEIGHT OF AN END USER. HOWEVER, DUE TO THE REPORTED INJURY AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    WHEN USING THE TRANSFER BENCH, THE END USER FELL AND SUFFERED A RIGHT LEG FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543386 TRANSFER BENCH ILS MEDLINE INDUSTRIES, INC. N130162158

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R