BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETAC WALKER ONO

    MDR report key: 2639461 · Received June 28, 2012

    Report

    Report Number
    3008986539-2012-00043
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Date of Event
    January 1, 2007
    Report Date
    January 30, 2007
    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

    Narratives

    Additional Manufacturer Narrative · 1

    THE WHEEL CAME OFF DURING HANDLING OF THE WALKER, BUT NO USER WAS INVOLVED. THE CIRCLIP THAT PREVENTS THE WHEEL FROM COMING OFF WAS OVER-EXTENDED. THE WHEEL AXLES OF THE WALKER WERE ACCORDING TO SPEC.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE WALKER LOST A REAR WHEEL. 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 15040105-14 NA

    Patients

    Seq Age Sex Outcome Treatment
    1