BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMEX

    MDR report key: 5051189 · Received September 2, 2015

    Report

    Report Number
    2428983-2015-00004
    Event Type
    Injury
    Date Received
    September 2, 2015
    Date of Event
    August 12, 2015
    Report Date
    September 1, 2015
    Manufacturer
    JAN MAO INDUSTRIES, CO, LTD.
    Product Code
    ILS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    END-USER'S DAUGHTER ALLEGES HER MOTHER WAS USING HER NEW RAISED TOILET SEAT WHEN SHE HEARD HER MOTHER SCREAM. WHEN SHE ENTERED THE BATHROOM SHE FOUND THE TOILET SEAT COMPLETELY OFF THE TOILET AND TILTED ON IT'S SIDE. HER MOTHER WAS LYING ON THE FLOOR. THE DEALER STATED THEY DELIVERED AND INSTALLED THE RAISED TOILET SEAT FOR THEIR CUSTOMER/END-USER. FOLLOWING THE INSTALLATION, THEY RECEIVED A CALL STATING THE TOILET SEAT WAS LOOSE. THE DEALER WENT BACK TO THE RESIDENCE TO RE-INSPECT THE PRODUCT. FINDING NO VISUAL MALFUNCTION OR DEFECT THE DEALER RE-INSTALLED THE TOILET SEAT AND INSTRUCTED THE CUSTOMER TO USE BOTH HANDS WHEN RISING OFF THE UNIT TO ENSURE EVEN DISTRIBUTION OF WEIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580604 LUMEX RAISED TOILET SEAT ILS JAN MAO INDUSTRIES, CO, LTD. 6487RA JAQ300BS

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention