BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREE SPIRIT KNEE WALKER

    MDR report key: 1515087 · Received October 19, 2009

    Report

    Report Number
    1056127-2009-00019
    Event Type
    Malfunction
    Date Received
    October 19, 2009
    Date of Event
    September 23, 2009
    Report Date
    September 24, 2009
    Manufacturer
    ESSENTIAL MEDICAL SUPPLY, INC.
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HIT THRESHOLD IN HOME WITH FRONT WHEELS AND THE LOCKING PIN ALLEGEDLY BROKE. PT FELL FORWARD AND CUT LEG ON TILLER BRACKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREE SPIRIT KNEE WALKER CRUTCH ALTERNATIVE ITJ ESSENTIAL MEDICAL SUPPLY, INC. P4000

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention