BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETAC WALKER ONO

    MDR report key: 2641814 · Received June 28, 2012

    Report

    Report Number
    3008986539-2012-00037
    Event Type
    Injury
    Date Received
    June 28, 2012
    Date of Event
    July 19, 2011
    Report Date
    September 8, 2011
    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 WHEEL HAD BEEN PUT BACK ON THE WALKER BEFORE IT WAS RETURNED TO ETAC FOR EVALUATION. THE CIRCLIP WAS CORRECTLY ASSEMBLED. THE CUSTOMER REPORTED THAT THE WALKER HAD NOT BEEN SERVICED. THE WHEEL AXLES OF THE WALKER WERE ACCORDING TO SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    THE RIGHT FRONT WHEEL OF THE WALKER CAME OFF WHILE THE USER WAS WALKING INDOORS. THE USER FELL AND HAD A RIGHT-SIDED CERVICAL HIP FRACTURE. THE USER GOT MEDICAL TREATMENT THE SAME DAY.

    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 UNK Hospitalization