BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARTRAC TRX TREADMILL (HEALTH CARE GRADE)

    MDR report key: 19648187 · Received June 28, 2024

    Report

    Report Number
    MW5156859
    Event Type
    Injury
    Date Received
    June 28, 2024
    Date of Event
    June 3, 2024
    Report Date
    June 25, 2024
    Manufacturer
    UNKNOWN
    Product Code
    IOL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE USING TREADMILL FOR CARDIA/PULMONARY REHAB, PATIENT STATES SHE SECURED THE SAFETY CLIP AND ADMITS TO SETTING THE SPEED TOO HIGH, INADVERTENTLY. WHILE GRABBING THE HANDLE TO KEEP FROM FALLING, PATIENT ACTUALLY INCREASED THE SPEED, CAUSING HER TO FALL AND FRACTURE HER SHOULDER, HUMERUS, AND 3 RIBS. PATIENT REQUIRED HOSPITALIZATION AND REHAB. PATIENT REPORTED FEELING FATIGUED PRIOR TO SESSION. HOWEVER, THE PATIENT HAD USED THE TREADMILL APPROXIMATELY 10 TIMES PRIOR WITH NO ISSUES. UNISON, INC., IRVINE, 92606.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684734 STARTRAC TRX TREADMILL (HEALTH CARE GRADE) TREADMILL, POWERED IOL UNKNOWN 9-9051-MUNBP0

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Hospitalization