BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4220222 · Received November 3, 2014

    Report

    Report Number
    1531186-2014-05283
    Date Received
    November 3, 2014
    Report Date
    October 8, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER ALLEGES, THE BOLT THAT ATTACHES THE HANDLE TO THE FRAME OF ROLLATOR WAS BENT OUT OF BOX. REF ORDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701214 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 66550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other