BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2862481 · Received December 10, 2012

    Report

    Report Number
    1531186-2012-01681
    Date Received
    December 10, 2012
    Report Date
    December 7, 2012
    Manufacturer
    CONSMA
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6) - NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES BRAKE HANDLE ON THE ROLLATOR IS DEFECTIVE. MDR FILED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other