BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETAC WALKER ONO

    MDR report key: 2639455 · Received June 28, 2012

    Report

    Report Number
    3008986539-2012-00010
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Date of Event
    April 29, 2007
    Report Date
    July 12, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OF THE WALKER'S REAR WHEELS HAD COME OFF. THE CIRCLIP THAT PREVENTS THE WHEEL FROM COMING OFF WAS MISSING. THE WHEEL AXLES OF THE WALKER WERE ACCORDING TO SPECIFICATION. ETAC REF. NO. (B)(4).

    Description of Event or Problem · 1

    THE USER WALKED ON THE PAVEMENT WHILE USING THE WALKER. THE RIGHT REAR WHEEL OF THE WALKER CAME OFF. THE USER DID NOT FALL. 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 UNK