BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETAC WALKER ONO

    MDR report key: 2639468 · Received June 28, 2012

    Report

    Report Number
    3008986539-2012-00036
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Date of Event
    June 23, 2011
    Report Date
    July 5, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CIRCLIP THAT PREVENTS THE WHEEL FROM COMINGOFF WAS LOOSE, BUT UNDAMAGED BEHIND THE WHEEL CAP. THE WHEEL AXLES OF THE WALKER WERE ACCORDING TO SPECIFICATION. ACCORDING TO ETAC'S CUSTOMER, THE WALKER HAD BEEN RECONDITIONED WITHOUT WHEEL CHANGE. ETAC REF. NO. (B)(4).

    Description of Event or Problem · 1

    THE USER RECEIVED THE WALKER ON (B)(6) 2011 AND HAD HAD ANOTHER WALKER OF THE SAME MODEL SINCE (B)(6) 2010. THE USER WAS WALKING ON A WOODEN FLOOR WHEN THE RIGHT REAR WHEEL FELL OFF. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETAC WALKER ONO WALKER MECHANICAL - ITJ ITJ ETAC SUPPLY CENTER AB 15041201-14 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK