BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2820036 · Received November 5, 2012

    Report

    Report Number
    1531186-2012-01344
    Date Received
    November 5, 2012
    Date of Event
    September 22, 2012
    Report Date
    November 5, 2012
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) - THE DEALER REPORTED THAT THE 6240-JR WALKER WHEEL BROKE DURING USE, RESULTING IN THE PATIENT FALLING, GETTING BRUISED WITH BLACK EYE, AND KNOCKED OUT A COUPLE HER TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 6240-JR

    Patients

    Seq Age Sex Outcome Treatment
    1 85 Other