BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3971047 · Received July 31, 2014

    Report

    Report Number
    1531186-2014-02930
    Date Received
    July 31, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 24, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BRAKES NOT WORKING ON EITHER SIDE. CONSUMER'S DAUGHTER STATES THAT HER MOTHER FELL AND HAD TO BE TAKEN TO THE EMERGENCY ROOM. SHE HAD A CATSCAN DONE. NO BROKEN BONES AND NO OPEN WOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448207 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization