BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETAC WALKER ONO

    MDR report key: 2639513 · Received June 28, 2012

    Report

    Report Number
    3008986539-2012-00034
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Date of Event
    April 14, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ETAC SUPPLY CENTER AB
    Product Code
    ITJ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    3008986539-1/27/12-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE WHEEL AXLES OF THE WALKER WERE ACCORDING TO SPECIFICATION. THE WHEEL HAS A BEARING PLACED IN A HOUSING ON EACH SIDE OF THE WHEEL. THE INNER SIDE OF THE TIRE AND INNER HOUSING OF THE LEFT REAR WHEEL WERE DAMAGED. THE OUTER BEARING HAD A MARK FROM THE EDGE OF THE CIRCLIP. (B)(4).

    Description of Event or Problem · 1

    ON THE MORNING OF (B)(6) 2011, HOME CARE STAFF REPORTED THAT THE LEFT REAR WHEEL OF THE WALKER HAD FALLEN OFF WHEN THE USER ROSE. THE USER HAD FALLEN THE NIGHT BEFORE, ON (B)(6) 2011. WHILE DRAWING THE CURTAIN, HE STUMBLED AND FELL, AND THE WALKER LANDED ON TOP OF HIM. NO INJURY TO THE USER WAS REPORTED. A PHYSIOTHERAPIST VISITED THE USER ON (B)(6) 2011 TO REPLACE THE WALKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETAC WALKER ONO WALKER MECHANICAL - ITJ ITJ ETAC SUPPLY CENTER AB 15040405-14 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK