BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDLINE LOCKING ELEVATED TOILET

    MDR report key: 1184787 · Received September 29, 2008

    Report

    Report Number
    1417592-2008-00030
    Event Type
    Other
    Date Received
    September 29, 2008
    Date of Event
    August 22, 2008
    Report Date
    September 23, 2008
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    INB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    END USER STATES SHE IS HANDICAPPED AS SHE HAD POLIO AND NOW HAS POST POLIO SYNDROME. SHE STATES SHE HAS DIFFICULTY TOILETING HERSELF. SHE WAS USING THE LOCKING TOILET SEAT FOR THE FIRST TIME AND ATTEMPTED TO TIGHTEN IT ON THE TOILET. SHE STATED THEY HAD DIFFICULTY GETTING IT TIGHT. SHE APPARENTLY WAS SITTING ON THE SEAT AND LEANED ON ONE OF THE ARMS. WHEN SHE DID THIS, IT TILTED AND SHE FELL. SHE WAS TRANSPORTED TO THE EMERGENCY ROOM AND A FRACTURED TIBIA WAS DIAGNOSED. THE LEG WAS SUBSEQUENTLY CASTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    END USER STATED SHE HAD DIFFICULTY GETTING THE SEAT TO LOCK ON THE TOILET BUT USED IT ANYWAY. SHE APPARENTLY LEANED ON ONE OF THE ARMS OF THE DEVICE, CAUSING IT TO TILT. SHE FELL AND SUFFERED A FRACTURED TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDLINE LOCKING ELEVATED TOILET NONE INB MEDLINE INDUSTRIES, INC. MDS80316H R070885948

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention