BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETAC WALKER AVANT

    MDR report key: 2639478 · Received June 28, 2012

    Report

    Report Number
    3008986539-2012-00047
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Date of Event
    July 20, 2011
    Report Date
    October 4, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CIRCLIP THAT PREVENTS THE WHEEL FROM COMING OFF THE WALKER HAD BEEN OVER-EXTENDED. THE WHEEL AXLES OF THE WALKER WERE ACCORDING TO SPEC. ACCORDING TO THE CUSTOMER, THE WALKER HAD BEEN SERVICED SEVERAL TIMES. (B)(4).

    Description of Event or Problem · 1

    THE LEFT FRONT WHEEL CAME OFF THE WALKER AND THE USER FELL BUT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETAC WALKER AVANT WALKER MECHANICAL - ITJ ITJ ETAC SUPPLY CENTER AB 15030103-15 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK