BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE DUAL RELEASE JUNIOR WALKER

    MDR report key: 24443671 · Received February 25, 2026

    Report

    Report Number
    1531186-2026-00002
    Event Type
    Injury
    Date Received
    February 25, 2026
    Date of Event
    December 13, 2024
    Report Date
    February 25, 2026
    Manufacturer
    FUJIAN XIANG XIN LIGHT ALLOY MANUFACTURING CO LTD
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT WALKER WAS MANUFACTURED IN 2018 MAKING THE UNIT APPROXIMATELY 6 YEARS OLD AT THE TIME OF THE INCIDENT. THE REPORTER ADVISED THE WALKER HAD BEEN PURCHASED IN 2021. ADDITIONAL INFORMATION HAS BEEN REQUESTED INCLUDING HOW AND WHERE THE WALKER WAS BEING USED WHEN THE INCIDENT OCCURRED. AT THIS TIME NO FURTHER INFORMATION HAS BEEN RECEIVED. WITHOUT THIS ADDITIONAL INFORMATION, THE UNDERLYING CAUSE OF THE INCIDENT AND IF A MALFUNCTION OCCURRED CANNOT BE DETERMINED THE DUAL RELEASE WALKERS 6291 SERIES USER MANUAL ADVISES THE LIFE OF THE PRODUCT WHEN USED IN ACCORDANCE WITH THE SAFETY INSTRUCTIONS, MAINTENANCE INTERVALS AND CARE INSTRUCTIONS IS FIVE YEARS. MAINTENANCE AND INSPECTION SHOULD BE DONE AT LEAST EVERY SIX MONTHS. AS PART OF THE MAINTENANCE, REGULAR INSPECTION OF PARTS INCLUDING HARDWARE, BRACKETS, AND PLASTICS, FOR DEFORMATION, CORROSION, BREAKAGE, WEAR OR COMPRESSION IS RECOMMENDED. REPLACE THE WALKER IF ANY OF THESE CONDITIONS EXIST. AT THIS TIME A RETURN IS NOT ANTICIPATED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE FILED.

    Description of Event or Problem · 0

    INVACARE WAS MADE AWARE ON JANUARY 28, 2026, OF AN INCIDENT INVOLVING A 6291-JR WALKER THAT OCCURRED ON (B)(6) 2024. IT WAS REPORTED THAT WHILE THE END USER WAS USING THE 6291-JR WALKER, THE FRONT LEFT LEG OF THE WALKER BROKE CAUSING HER TO FALL TO THE GROUND. WHEN SHE FELL FORWARD, THE METAL PIECE OF THE WALKER WENT THROUGH HER ARM, RESULTING IN 16 STITCHES. SHE ALSO SUSTAINED FRACTURES TO HER LUMBAR (COMPRESSION FRACTURE OF L2) AND THORACIC REGION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502941 INVACARE DUAL RELEASE JUNIOR WALKER WALKER, MECHANICAL ITJ FUJIAN XIANG XIN LIGHT ALLOY MANUFACTURING CO LTD 6291-JR FX181201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| R