BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3298807 · Received August 20, 2013

    Report

    Report Number
    1531186-2013-03937
    Date Received
    August 20, 2013
    Report Date
    August 9, 2013
    Manufacturer
    CONSMA
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOLLOW UP #001. INITIAL PR (B)(4) ISSUED MFR. REPORT # 1531186-2013-03937, INDICTING THE BRAND NAME AS A MECHANICAL (MANUAL) WHEELCHAIR WHEN THE PRODUCT IS IN FACT A MECHANICAL WALKER, ROLLATOR. THE DEVICE NAME HAS ALSO BEEN CORRECTED FROM 890.3850 TO 890.3825.

    Description of Event or Problem · 1

    THE END USER STATES THE WHEELS ARE ALL WEARING DOWN.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401672 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ CONSMA 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other