BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2820017 · Received November 5, 2012

    Report

    Report Number
    1531186-2012-01337
    Date Received
    November 5, 2012
    Report Date
    November 3, 2012
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(6) (HOME HEALTH THERAPIST) CALLED TO REPORT TO US THAT ALLEGEDLY THE WALKER (B)(6) IS USING IS WOBBLY. SHE ALLEGES THAT THE SCREWS SEEM AS THOUGH THEY NEED TO BE TIGHTENED. SHE ALLEGES HE HAS HAD THIS WALKER ABOUT 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 6300-JRA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other