BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2820064 · Received November 5, 2012

    Report

    Report Number
    1531186-2012-01350
    Date Received
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4) - IT WAS REPORTED BY THE CONSUMER THAT THE 65650 ROLLATOR FRAME WAS BROKEN AT THE WELD, AND THE SEAT WAS LOOSE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other