BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4211618 · Received October 29, 2014

    Report

    Report Number
    9615290-2014-00156
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 8, 2014
    Manufacturer
    DOLOMITE AB
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE BRAKES, BOTH SIDES, ON A JAZZSTD ROLLATOR, ARE POPPING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691638 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ DOLOMITE AB JAZZSTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other