BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3081511 · Received April 29, 2013

    Report

    Report Number
    1531186-2013-01796
    Date Received
    April 29, 2013
    Report Date
    April 2, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES THE DEVICE HAS A LOCK IN THE SUPPORT ARM THAT GOES TO THE TIRE, AND IT KEEPS COMING UNSCREWED. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185797 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 66550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other