BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREX

    MDR report key: 6799790 · Received August 17, 2017

    Report

    Report Number
    3005739540-2017-00007
    Event Type
    Malfunction
    Date Received
    August 17, 2017
    Date of Event
    June 18, 2017
    Report Date
    August 17, 2017
    Manufacturer
    COM-BRIDGE INTERNATIONAL CO.,LTD
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE INJURY/FAILURE OCCURRED ON (B)(6) 2017. THE END-USER SCREAMED, AS THE INITIAL REPORTER (END-USER'S HUSBAND) RAN OUTSIDE. THE END-USER IS REPORTED AS HAVING BEEN IN SLIPPERS, SLIPPED ON THE STEPS, OUT FEEDING SQUIRRELS (SAID THE WORD SLIPPED & STAIRS) - TRANSITIONED TO POOR QUALITY/THIN METAL. THE USER IS REPORTED AS HAVING HIT HER HEAD, AND SHE HAS A VISIBLE KNOT - SHE ALSO AGGRAVATED A PRE-EXISTING FRACTURE IN HER ANKLE. ON (B)(6) 2017, COMPASS HEALTH BRANDS SPOKE TO THE END-USER'S HUSBAND, WHO STATED THAT THE ROLLATOR WAS PURCHASED FOR USE TO GET AROUND. THE USER WAS DOING SOMETHING IN THE KITCHEN WHEN SHE FELL. THE FRAME BROKE WHERE THE WHEEL ATTACHED TO THE FRAME. THE DEVICE INVOLVED WITH THIS EVENT WAS RETURNED TO THE STORE IT WAS PURCHASED FROM. THE USER IS REPORTED AS BEING TERRIFIED TO THE "SERIOUS INJURY" REPORTING CLASSIFICATION WAS DETERMINED BY COMPASS HEALTH BRANDS (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581583 CAREX STREET ROLLING WALKER ITJ COM-BRIDGE INTERNATIONAL CO.,LTD FGA221000000

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other