BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2940068 · Received February 1, 2013

    Report

    Report Number
    1531186-2013-00363
    Date Received
    February 1, 2013
    Report Date
    January 31, 2013
    Manufacturer
    CONSMA
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 SEAT BROKE ON ROLLATOR. IT SNAPPED IN HALF. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44721 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ CONSMA 65851B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other