BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREADMILL

    MDR report key: 19298196 · Received May 10, 2024

    Report

    Report Number
    MW5154765
    Event Type
    Injury
    Date Received
    May 10, 2024
    Report Date
    May 9, 2024
    Manufacturer
    FULL VISION, INC.
    Product Code
    IOL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS LETTER IS TO INFORM YOU OF AN EVENT THAT OCCURRED AT (B)(6) HOSPITAL IN SPAIN ON MARCH 22, 2024, IN WHICH IT WAS ALLEGED A TREADMILL (TM2100ST) STARTED MOVING WITHOUT ANY USER INTERACTION WHILE PATIENT WAS ON IT. THE PATIENT SUBSEQUENTLY FELL WHICH RESULTED IN A FRACTURED NOSE. (B)(6) DOES NOT MANUFACTURE THIS TREADMILL. THE TM2100 ST IS MANUFACTURED BY FULL VISION INC. WHICH IS IN UNITED STATES. FULL VISION INC. WAS INFORMED OF THIS EVENT ON MAY 1ST, 2024. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776861 TREADMILL TREADMILL, POWERED IOL FULL VISION, INC. TM2100 ST

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown