BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETAC WALKER ONO

    MDR report key: 2639477 · Received June 28, 2012

    Report

    Report Number
    3008986539-2012-00042
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Date of Event
    January 9, 2008
    Report Date
    January 24, 2008
    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 WAS OVER-EXTENDED. THE WHEEL AXLES WERE ALL ACCORDING TO SPEC. ACCORDING TO ETAC'S CUSTOMER, THE WHEEL HAD NOT BEEN CHANGED. ETAC REF# (B)(4).

    Description of Event or Problem · 1

    REPORTED BY HEALTH PROFESSIONAL. THE REAR WHEEL CAME OFF WHEN THE THERAPIST DELIVERED THE WALKER, ON (B)(6) 2007. THE WALKER WAS NOT USED BY ANY USER DURING THE PERIOD (B)(6) 2007 TO (B)(6) 2008. 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 15041201-14 NA

    Patients

    Seq Age Sex Outcome Treatment
    1