BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVE HEALTH LLC

    MDR report key: 23348845 · Received October 21, 2025

    Report

    Report Number
    3011191255-2025-00013
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    August 16, 2025
    Report Date
    October 1, 2025
    Manufacturer
    VIVE HEALTH
    Product Code
    ITJ
    UDI-DI
    00818323027952
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER EXPERIENCED A FALL AND FRACTURED HER FIBULA. SHE REQUIRED SURGERY FOLLOWED BY PHYSICAL THERAPY. THE INCIDENT OCCURRED AS SHE WAS TURNING THE CORNER FROM HER KITCHEN TO HER BATHROOM, WHERE SHE LOST HER BALANCE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2354743 VIVE HEALTH LLC 3 WHEEL WALKER ROLLATOR MOB1026 ITJ VIVE HEALTH MOB1026 00818323027952

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention