BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETAC WALKER ONO

    MDR report key: 2639486 · Received June 28, 2012

    Report

    Report Number
    3008986539-2012-00022
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Date of Event
    June 30, 2009
    Report Date
    August 6, 2009
    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 WALKER'S LEFT REAR WHEEL HAD COME OFF. THE CIRCLIP THAT PREVENTS THE WHEEL FROM COMING OFF HAD BEEN OVER-EXTENDED. THE WHEEL AXLES OF THE WALKER WERE ACCORDING TO SPECIFICATION. ACCORDING TO THE CUSTOMER, THE WHEELS HAD NEVER BEEN REPLACED. HOWEVER, THE WHEEL THAT CAME OFF WAS LESS DUSTY AND LESS WORN THAN THE OTHER THREE WHEELS. IN ADDITION, THE CIRCLIPS OF THE THREE WHEELS THAT HAD NOT COME OFF WERE SLIGHTLY OVER-EXTENDED, AND THE WHEEL AXLES WERE LUBRICATED WITH A GREASE THAT ETAC DOES NOT USE. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER RECEIVED AN ONO WALKER WITH A WHEEL THAT HAD FALLEN 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 15040105-14 NA

    Patients

    Seq Age Sex Outcome Treatment
    1