BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADENSE INC

    MDR report key: 23387793 · Received October 25, 2025

    Report

    Report Number
    3039167356-2025-00001
    Event Type
    Injury
    Date Received
    October 25, 2025
    Date of Event
    September 6, 2025
    Report Date
    October 25, 2025
    Manufacturer
    CADENSE INC.
    Product Code
    KNP
    UDI-DI
    00810195430564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER INVESTIGATION, IT WAS DISCOVERED THAT THE USER DID NOT UNDERSTAND THE TECHNOLOGY IN THE SHOES. SHE DID NOT READ THE INFORMATIONAL PLACARD OR WATCH THE VIDEOS EMAILED TO HER AFTER PURCHASE. SHE ACKNOWLEDGED RECEIVING BOTH BUT NOT PAYING ATTENTION TO THEM. MULTIPLE MEETINGS OF CADENSE MANAGEMENT TOOK PLACE TO DISCUSS OPTIONS TO BETTER EDUCATE CUSTOMERS. THE CORRECTIVE ACTION IS STILL TO BE DETERMINED.

    Description of Event or Problem · 0

    CUSTOMER WAS WEARING CADENSE ORIGINAL SHOES WHILE WORKING AS A CLEANING PERSON AT PANERA BREAD. THE GROUND WAS WET CONCRETE, SLOPING DOWNWARD SLIGHTLY. SHE SLIPPED AND FELL TO THE GROUND, WHICH LED TO A BROKEN ANKLE. SHE CALLED AN AMBULANCE TO HELP HER OFF THE GROUND AND ULTIMATELY GOT SURGERY ON HER ANKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1551127 CADENSE INC ORIGINAL WOMEN'S R3 KNP CADENSE INC. SHORW N/A 00810195430564

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention| H