BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2912074 · Received January 11, 2013

    Report

    Report Number
    1531186-2013-00154
    Date Received
    January 11, 2013
    Report Date
    January 10, 2013
    Manufacturer
    KENSTONE METAL
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THIS EVENT, ALTHOUGH TWO DIFFERENT COMPLAINTS WERE CREATED BECAUSE OF DIFFERENT PARTS NEEDED TO REPAIR THE UNIT, AND THE NUMBERS ARE THE FOLLOWING: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) -THE DEALER REPORTED THAT THE 66550 ROLLATOR HANDLES WERE BROKEN. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16940 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ KENSTONE METAL 66550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other