BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETAC WALKER ONO

    MDR report key: 2639469 · Received June 28, 2012

    Report

    Report Number
    3008986539-2012-00007
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Date of Event
    July 1, 2006
    Report Date
    August 3, 2006
    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 HAD COME OFF DURING HANDLING OF THE WALKER. NO USER WAS INVOLVED. THE CIRCLIP THAT PREVENTS THE WHEEL FROM FALLING OFF WAS LOOSE, BUT UNDAMAGED BEHIND THE WHEEL CAP. THE WHEEL AXLES OF THE WALKER WERE ACCORDING TO SPECIFICATION. ETAC REF. NO. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT. THE WALKER HAD LOST A REAR WHEEL. THE CUSTOMER ASKED ETAC TO EXAMINE THE WALKER. 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 15040105-33 NA

    Patients

    Seq Age Sex Outcome Treatment
    1