BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2993279 · Received March 7, 2013

    Report

    Report Number
    1525712-2013-01727
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 11, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    PROVIDER STATES THE ROLLATOR WANTS TO FOLD UP WHEN HITTING A BUMP OR ANYTHING LIKE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97113 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other