BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2832820 · Received November 14, 2012

    Report

    Report Number
    1531186-2012-01395
    Date Received
    November 14, 2012
    Date of Event
    October 15, 2012
    Report Date
    November 12, 2012
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) - IT WAS REPORTED BY THE CONSUMER THAT THE 6300-JRA WALKER RIGHT LEG GOT BENT AND BROKE AT THE WELD, AND THE PATIENT FELL. THERE WAS NO INJURY REPORTED.

    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 53 Other