BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETAC WALKER ONO

    MDR report key: 2641811 · Received June 28, 2012

    Report

    Report Number
    3008986539-2012-00023
    Event Type
    Injury
    Date Received
    June 28, 2012
    Date of Event
    April 22, 2009
    Report Date
    September 18, 2009
    Manufacturer
    ETAC SUPPLY CENTER AB
    Product Code
    ITJ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    3008986539-1/27/12-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE WALKER'S LEFT REAR WHEEL CAME OFF. THE CIRCLIP THAT PREVENTS THE WHEEL FROM COMING OFF HAD BEEN OVER-EXTENDED. THE WHEEL AXLES OF THE WALKER WERE ACCORDING TO SPECIFICATION. THE WALKER WAS 9 YEARS OLD. (B)(4).

    Description of Event or Problem · 1

    THE USER WAS ALONE IN HIS ROOM WHEN THE RIGHT REAR WHEEL OF THE WALKER CAME OFF AND HE FELL. HE HAD A RIB FRACTURE AND BRUISES ON HIS BUTTOCKS AND RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETAC WALKER ONO WALKER MECHANICAL - ITJ ITJ ETAC SUPPLY CENTER AB 15040101-33 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization