BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3243259 · Received July 23, 2013

    Report

    Report Number
    1531186-2013-03324
    Date Received
    July 23, 2013
    Report Date
    July 2, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE 65650 ROLLATOR BRAKES ARE NO LONGER WORKING PROPERLY. THE PATIENT APPLIED THE BRAKES, HOWEVER, THE ROLLATOR ROLLED OUT FROM UNDERNEATH HER CAUSING HER TO FALL. THE PATIENT PRESENTED TO THE ER SOME TIME AFTER HER FALL, COMPLAINING OF PAIN IN HER BACK AND LEFT ARM. THE PATIENT UNDERWENT MEDICAL THERAPY SERVICES. THE NATURE AND LENGTH OF THE ABOVE-REFERENCED SERVICES AND DETAILS REGARDING THE SEVERITY OF THE PATIENT'S INJURIES WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343912 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 74 Other| R