BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVA MONARCH BUTTERFLY ROLLATOR

    MDR report key: 21873945 · Received April 21, 2025

    Report

    Report Number
    MW5169333
    Event Type
    Injury
    Date Received
    April 21, 2025
    Date of Event
    March 3, 2025
    Report Date
    April 15, 2025
    Manufacturer
    NOVA ORTHO-MED, INC.
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CAN'T LOCK THE RIGHT HAND SIDE BREAK. FOLDING MECHANISM BECAME LOOSE. PARTS FELL OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257643 NOVA MONARCH BUTTERFLY ROLLATOR WALKER, MECHANICAL ITJ NOVA ORTHO-MED, INC. 4239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention