BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVE HEALTH LLC

    MDR report key: 21241169 · Received January 27, 2025

    Report

    Report Number
    3011191255-2025-10002
    Event Type
    Injury
    Date Received
    January 27, 2025
    Date of Event
    October 19, 2024
    Report Date
    January 23, 2025
    Manufacturer
    VIVE HEALTH
    Product Code
    ITJ
    UDI-DI
    00818323029581
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    SHE RECEIVED THE PRODUCT, THEY ASSEMBLED AND WHEN SHE FIRST TRIED TO USE IT, IT TIPPED OVER AND SHE FELL WITH IT, LUCKILY SHE FELL ON HER DOG'S BED AND HAS A MINOR BRUISE SHE'S OKAY BUT IT IS EXTREMELY UNSAFE FOR HER TO USE IT. SOMEONE ELSE TREID TO USE IT AS WELL AND IT KEPT HAPPENING, THEY LOOKED AT THE PRODUCT AND IT SEEMS LIKE THE BOTTOM IS NARROWER THAN THE TOP MAKING IT UNSTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830438 VIVE HEALTH LLC UPRIGHT WALKER MOB1033 ITJ VIVE HEALTH MOB1033 00818323029581

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Female Required Intervention