BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELENKER STEERABLE KNEE WALKER MEDICAL SCOOTER

    MDR report key: 22133429 · Received June 3, 2025

    Report

    Report Number
    MW5171038
    Event Type
    Injury
    Date Received
    June 3, 2025
    Date of Event
    May 24, 2025
    Report Date
    May 27, 2025
    Manufacturer
    ELENKER FUZHOU FEIWO TRADING CO. LTD
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WHILE USING ELENKER KNEE WALKER PATIENT EXPERIENCED SUDDEN STRUCTURAL FRAME FAILURE CAUSING FALL AND INJURY. AFTER PROVIDING ONLINE NEGATIVE REVIEW OF PRODUCT MULTIPLE OTHER IDENTICAL/SIMILAR EVENTS WERE NOTED WITH IMAGES AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78163 ELENKER STEERABLE KNEE WALKER MEDICAL SCOOTER WALKER, MECHANICAL ITJ ELENKER FUZHOU FEIWO TRADING CO. LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female