BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELENKER ROLLATER WALKER

    MDR report key: 23995397 · Received January 7, 2026

    Report

    Report Number
    MW5181925
    Event Type
    Injury
    Date Received
    January 7, 2026
    Date of Event
    December 28, 2025
    Report Date
    January 5, 2026
    Manufacturer
    FUZHOU FEIWO TRADING CO.,LTD
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS USING THE ELENKER ROLLATER WALKER. WHEN HE WENT TO SIT DOWN, THE CROSSBAR BROKE CAUSING THE PATIENT TO FALL ON THE GROUND. PATIENT HAS USED THE WALKER FOR TWO MONTHS WITH NO ISSUES. THE WALKER WAS NOT COMPROMISED BY ANY COLLISION PRIOR TO THE INCIDENT. THE WALKER IS SUPPOSED TO HAVE A 500LBS WEIGHT CAPACITY. PATIENT'S FIANCEE IS THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61162 ELENKER ROLLATER WALKER WALKER, MECHANICAL ITJ FUZHOU FEIWO TRADING CO.,LTD YF9007A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other| R