BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING ELEVATED TOILET SEAT

    MDR report key: 1419596 · Received July 20, 2009

    Report

    Report Number
    1417592-2009-00038
    Event Type
    Injury
    Date Received
    July 20, 2009
    Date of Event
    June 13, 2009
    Report Date
    July 17, 2009
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    INB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE END USER FELL AS HE WAS GETTING UP FROM THE ELEVATED TOILET SEAT. THE SEAT DETACHED AND HE FELL FORWARD, FRACTURING RBS AND VERTEBRAE. THE SEAT HAD BEEN USED FOR A COUPLE OF MONTHS AND IT WAS REPORTED THAT THE END USER CONTINUED TO USE IT DESPITE THE FACT IT WOULD NOT STAY SECURE AND HE WOULD TIP FORWARD. THE END USER WAS HOSPITALIZED. WE HAVE RECEIVED NO FURTHER INFORMATION PERTAINING TO HIS INJURIES OR CONDITION. THE SAMPLE HAS NOT BEEN RETURNED TO US. NO LOT NUMBER WAS PROVIDED. WE HAVE NO SAMPLE TO EVALUATE AND CANNOT DETERMINE A POTENTIAL ROOT CAUSE FOR THE REPORTED INCIDENT. HOWEVER, DUE TO THE INJURY REPORTED A MEDWATCH IS BEING REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER WAS LEANING FORWARD TO GET UP FROM THE TOILET SEAT, AND IT DETACHED. HE FELL FORWARD AND FRACTURED RIBS AND VERTEBRAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING ELEVATED TOILET SEAT NONE INB MEDLINE INDUSTRIES, INC. MDS80316 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention