BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2820002 · Received November 5, 2012

    Report

    Report Number
    1531186-2012-01339
    Date Received
    November 5, 2012
    Date of Event
    October 11, 2012
    Report Date
    November 3, 2012
    Manufacturer
    CONSMA
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). INJURY ALLEGED. MALFUNCTION ALLEGED. THE DEALER ALLEGES THAT ONE OF THE BRAKES WAS BROKEN WHEN THE CONSUMER STOOD UP ONLY ONE BRAKE WORKED AND THEN SHE FELL TO HER KNEES AND ROLLED TO HER SIDE. PER FOLLOW UP CALL BY CONSUMER AFFAIRS, THE CONSUMER SUSTAINED BRUISING ON THE SHOULDER AND THE KNEE. THE CONSUMER DID NOT SEEK MEDICATION ATTENTION. THE ORIGINAL UNIT IS GOING TO BE RETURNED. THE RMA NUMBER IS (B)(4). MDR FILED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 88 Other