BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4242348 · Received November 11, 2014

    Report

    Report Number
    1531186-2014-05519
    Date Received
    November 11, 2014
    Report Date
    October 22, 2014
    Manufacturer
    DANYANG MAXTHAI MEDICAL EQUIPMENT
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER KEY ACCOUNT SPECIALIST, "AHM, HAS (7) OF 65650 THAT HAVE BAD BRAKES OUT OF THE BOX. THEY¿RE STATING THAT WHEN THE BRAKE IS ENGAGED ON THE WHEEL, EVEN WITHOUT PRESSING ON THE BRAKE HANDLE AS TO PUSH THE UNIT, THE ROLLATOR DRAGS. LOT NUMBER IS MX140515. LET ME KNOW IF YOU HAVE ANY FURTHER QUESTIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727308 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ DANYANG MAXTHAI MEDICAL EQUIPMENT 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other