BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2914704 · Received January 14, 2013

    Report

    Report Number
    1531186-2013-00206
    Date Received
    January 14, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 14, 2013
    Manufacturer
    CONSMA
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) - THE DEALER REPORTED FIVE DIFFERENT 65650 ROLLATORS, AND THE COMPLAINTS NUMBERS ARE THE FOLLOWING: 48735 (B)(6), 48684 (B)(6), 48676 (B)(6), 48681 (B)(6), AND 48772 (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) -THE DEALER REPORTED THAT THE 65650 ROLLATOR SEAT WAS CRACKED ABOUT THREE INCHES DEEP. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21566 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ CONSMA 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other