BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2990623 · Received March 5, 2013

    Report

    Report Number
    1031452-2013-00478
    Date Received
    March 5, 2013
    Report Date
    February 8, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE, MDR 1031452-2013-00478 WAS INADVERTENTLY SUBMITTED UNDER THE INCORRECT MANUFACTURER REGISTRATION NUMBER. THE CORRECT MANUFACTURER REGISTRATION NUMBER IS 1531186.

    Description of Event or Problem · 1

    (B)(4) THE DEALER REPORTED THAT THE 65650 ROLLATOR WOULD NOT BRAKE WHILE THE END USER WAS SITING ON THE UNIT. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94275 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other