BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROLLATORS-615

    MDR report key: 19348125 · Received May 18, 2024

    Report

    Report Number
    3014644996-2024-00003
    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
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    LEFT HAND BRAKE HANDLE IS LOOSE AND IT DOESN'T MAKE WHEELS STOP WHEN SHE SQUEEZES THE BRAKE. SHE MENTIONED ADJUSTMENTS WERE MADE BUT THE ISSUE STILL REMAINS, THIS WAS PURCHASED ON (B)(6) 2023 AND IN USE SINCE THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642658 ROLLATORS-615 WALKER ITJ COM-DA HEALTHCARE CO.,LTD 1-FGA22100 0000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown