BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3031697 · Received April 2, 2013

    Report

    Report Number
    1531186-2013-01369
    Date Received
    April 2, 2013
    Report Date
    March 6, 2013
    Manufacturer
    CONSMA
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER END USER FRONT LEFT CASTER BROKE OFF. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133734 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ CONSMA 65851B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other