BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVE HEALTH LLC

    MDR report key: 21241183 · Received January 27, 2025

    Report

    Report Number
    3011191255-2025-10003
    Event Type
    Injury
    Date Received
    January 27, 2025
    Date of Event
    October 21, 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 COMPANY ALREADY REPLACED THE FAULTY UNIT WITH ONE IN STOCK, SHE WAS ABOUT TO USE THE KNEE WALKER UNTIL THE BREAKS FAIL AND SHE FELT DOWN, WHEN HIS HUSBAND TRY TO PICK HER UP AND SEE WHAT HAPPENED HE END ALSO FALLING DOW. THEY DECIDE NOT GOING INTO THE HR BUT SHE HAS BRUISES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831433 VIVE HEALTH LLC KNEE WALKER MOB1007 ITJ VIVE HEALTH MOB1007 00818323024937

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention