BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3921178 · Received July 9, 2014

    Report

    Report Number
    9615290-2014-00052
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 5, 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

    IT WAS REPORTED THAT THE BRAKE HANDLES KEEP POPPING AND NOT HOLDING ON THE (B)(4) WALKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399532 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ DOLOMITE AB 12220-02-35-87

    Patients

    Seq Age Sex Outcome Treatment
    1 Other