BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3243733 · Received July 23, 2013

    Report

    Report Number
    1531186-2013-03342
    Date Received
    July 23, 2013
    Report Date
    July 5, 2013
    Manufacturer
    KENSTONE METAL
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT # 1531186-2013-03342 INDICTING THE BRAND NAME AS A POWER CHAIR, THE COMMON DEVICE NAME AS 890.3860 AND THE PRODUCT CODE AS ITI. THE CORRECT BRAND NAME IS MECHANICAL, WALKER, ROLLATOR, COMMON DEVICE NAME IS 890.3825.

    Description of Event or Problem · 1

    PROVIDER STATES THE KNOB THAT TIGHTENS THE HANDLE CAME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344037 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ KENSTONE METAL 66550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other