BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVE HEALTH LLC

    MDR report key: 21241187 · Received January 27, 2025

    Report

    Report Number
    3011191255-2025-10004
    Event Type
    Injury
    Date Received
    January 27, 2025
    Date of Event
    October 24, 2024
    Report Date
    January 23, 2025
    Manufacturer
    VIVE HEALTH
    Product Code
    ITJ
    UDI-DI
    00818323024937
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER RECENTLY HAD FOOT SURGERY, AND WHILE USING THE ITEM, SHE FELL AND HIT THE FOOT THAT UNDERWENT SURGERY. SHE REPORTS THAT THIS HAPPENED BECAUSE THE ITEM IS TOO UNSTABLE AND DANGEROUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831437 VIVE HEALTH LLC KNEE WALKER ITJ VIVE HEALTH MOB1007 00818323024937

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention