BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT FOOTWEAR

    MDR report key: 2546137 · Received April 18, 2012

    Report

    Report Number
    3009089619-2012-00001
    Event Type
    Injury
    Date Received
    April 18, 2012
    Date of Event
    April 28, 2011
    Manufacturer
    MASAI MARKETING + TRADING AG
    Product Code
    KNP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    WHILE WALKING, HIS FOOT TURNED "INWARD." IT WAS PAINFUL FOR HIM TO WALK. HE WENT TO AN ER AND WAS DIAGNOSED WITH A FRACTURED FIBULA. HE WORE A SOFT CAST THEN A CAST/BOOT FOR 3 WEEKS. REPORTS LINGERING PAIN AND ANKLE WEAKNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MBT FOOTWEAR ORTHOSES, CORRECTIVE SHOE KNP MASAI MARKETING + TRADING AG FORA GTX

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention