BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5 IN FIXED DUAL RELEASE WALKER 9153634176

    MDR report key: 9587525 · Received January 14, 2020

    Report

    Report Number
    1531186-2020-00003
    Event Type
    Injury
    Date Received
    January 14, 2020
    Report Date
    August 26, 2019
    Manufacturer
    FUJIAN XIANG XIN HARDWARE TECHNOLOGY CO. LTD
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION GATHERED FROM THE DEALER PROVIDED THAT THE END USER LOST HIS BALANCE WHILE USING THE 6291-5F INVACARE WALKER OUTSIDE ON THE CONCRETE. THE DEALER STATED, ¿THE HANDLES WERE JUST WOBBLY, NOT THE WHOLE ROLLATOR¿. ALSO, THEY ARE NOT SURE IF THE END USER LOST HIS BALANCE AND FELL ON THE WALKER OR IF IT WAS THE FAULT OF THE WALKER. THE WALKER WAS REQUESTED TO BE RETURNED, HOWEVER THE DEALER WAS UNABLE TO LOCATE IT. THE WALKER HAS BEEN REPLACED. THE END USER DID NOT RECEIVE ANY MEDICAL TREATMENT FOR THE FRACTURED NOSE. THE OWNER¿S MANUAL FOR THIS DEVICE INCLUDES THE FOLLOWING WARNINGS/INSTRUCTIONS: MAINTENANCE SHOULD BE DONE AT LEAST EVERY SIX MONTHS. 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. ENSURE THE HANDGRIPS DO NOT TWIST ON SIDE FRAME. THE HANDGRIPS MUST BE TIGHT. DO NOT USE THE WALKER IF THE HANDGRIPS ARE LOOSE. REPLACE THE WALKER IF THE HANDGRIPS ARE LOOSE ON THE SIDE FRAME(S).

    Description of Event or Problem · 1

    THE END USER WAS USING THE WALKER OUTSIDE AND FELL FORWARD, FRACTURING HIS NOSE. HE CLAIMED THE HANDLES WERE WOBBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51545 5 IN FIXED DUAL RELEASE WALKER 9153634176 WALKER ITJ FUJIAN XIANG XIN HARDWARE TECHNOLOGY CO. LTD NA:6291-5F FX180801

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Other