BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4242418 · Received November 11, 2014

    Report

    Report Number
    1531186-2014-05516
    Date Received
    November 11, 2014
    Date of Event
    October 30, 2014
    Report Date
    November 10, 2014
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE 68100-TA ROLLATOR IS WOBBLY LEFT TO RIGHT, UNIT CANNOT BE TIGHTENED. END USER REPORTED THAT THE ROLLATOR HAD BEEN A LITTLE WOBBLY AND HE WAS USING THE UNIT WITH THE SEAT DOWN TO TRY AND MAKE IT MORE STURDY. USER ALSO REPORTED THAT HE MISSED A STEP OUTSIDE A HOTEL AND FELL ON THE ROLLATOR, THUS MAKING THE UNIT A LOT MORE WOBBLY AFTER THE ACCIDENT. USER REPORTED THAT HIS RIGHT KNEE WAS HURT DUE TO THE FALLING ACCIDENT, WAS IN THE HOSPITAL FOR A DAY OR TWO AND THEN TRANSFERRED TO REHAB FOR 10 DAYS. HE WILL REQUIRE REHAB IN THE HOME TWICE A WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726938 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 68100-TA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other