BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROLLATORS-615

    MDR report key: 19348123 · Received May 18, 2024

    Report

    Report Number
    3014644996-2024-00008
    Event Type
    Malfunction
    Date Received
    May 18, 2024
    Report Date
    May 18, 2024
    Manufacturer
    COM-DA HEALTHCARE CO.,LTD
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    I HAVE RECENTLY BEGUN USING MY MODEL RLAB8BG BARIATRIC ROLLATOR W/8" WHEELS AND ALMOST IMMEDIATELY THE BRAKE CABLE ON THE LEFT-HAND SIDE FRAYED AND BROKE SO THAT IT DID NOT ENGAGE THE BRAKE WHEN ACTIVATED. I NEED A NEW CABLE AND INSTRUCTIONS ON INSTALLATION. I TRIMMED THE CABLE WHERE IT FRAYED, THINKING I COULD FIX IT MYSELF BUT WHEN I OPENED IT UP, I REALIZED I NEEDED A NEW CABLE SINCE IT HAD BARRELS ON EACH END. OH WELL, I TRIED. I FORGOT TO MENTION THAT THE BRAKE LINE FRAYED WHEN I WAS USING IT TO STOP THE DEVICE. AS YOU CAN SEE, IT IS IN EXCELLENT CONDITION AS I ONLY USED IT ABOUT SIX OR EIGHT TIMES BEFORE THIS HAPPENED. I THOUGHT I HAD ATTACHED THE PHOTOS IN MY LAST EMAIL. I WAS 270 LBS. AND AM NOW AROUND 220. THE CABLE FRAYED AFTER USING THE BRAKE AROUND 15 TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855690 ROLLATORS-615 WALKER ITJ COM-DA HEALTHCARE CO.,LTD 1-RLAB8BG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown