BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARCO POST OP SHOE

    MDR report key: 2542841 · Received April 16, 2012

    Report

    Report Number
    9616086-2012-00024
    Event Type
    Injury
    Date Received
    April 16, 2012
    Date of Event
    March 21, 2012
    Report Date
    April 16, 2012
    Manufacturer
    DJO, LLC
    Product Code
    KNP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE WALKING DOWN STEPS WITH SANDPAPER STYLE GRIP, THE SOLE OF THE POST-OP SHOE SEPARATED FORM THE UPPER AND THE PT FELL. HE WAS TAKEN TO HIS TREATING PHYSICIAN'S OFFICE BY HIS GRANDMOTHER AND X-RAYS WERE TAKEN. PT WAS PLACED BACK IN A MAXTRAX WALKER FOR TWO WEEKS. WHILE NO MENTION OF ADDITIONAL INJURY IS MENTIONED, THE USE OF A STURDIER SUPPORT POST INCIDENT SUGGEST THAT ADDITIONAL INJURY WAS POSSIBLE. DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DARCO POST OP SHOE KNP DJO, LLC 7-8113

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other