BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3911433 · Received July 3, 2014

    Report

    Report Number
    1531186-2014-02366
    Date Received
    July 3, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 2, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    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 CUSTOMER WHILE WALKING WITH THEIR ROLLATOR THE FRAME BROKE IN TWO PLACES, DISCONNECTED FROM WELD ON ANOTHER SPOT AND 3OF THE 4 LEGS WERE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390623 MECHANICAL WALKER, ROLLATOR 890.3825 ITI UNKNOWN 65650R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other