BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREADMILL

    MDR report key: 17488582 · Received August 9, 2023

    Report

    Report Number
    MW5121281
    Event Type
    Injury
    Date Received
    August 9, 2023
    Date of Event
    April 25, 2023
    Report Date
    May 4, 2023
    Manufacturer
    FULL VISION, INC.
    Product Code
    IOL
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS LETTER IS TO INFORM YOU OF AN EVENT THAT OCCURRED AT (B)(6) IN COLOMBIA ON (B)(6) 2023, IN WHICH IT WAS ALLEGED THE TREADMILL (TM2100ST) BELT BEGAN MOVING WITHOUT USER INTERACTION WHILE THE PATIENT WAS ON IT. THE PATIENT FELL WHICH RESULTED IN INJURIES AND HOSPITALIZATION. 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
    2100436 TREADMILL TREADMILL, POWERED IOL FULL VISION, INC. TM2100 ST

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown