BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVATOR POST-OPERATIVE KNEE BRACE

    MDR report key: 1180043 · Received March 11, 2008

    Report

    Report Number
    2020250-2008-00001
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    June 22, 2007
    Report Date
    January 31, 2008
    Manufacturer
    OSSUR AMERICAS
    Product Code
    ITQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WE RECEIVED NOTIFICATION OF THIS ISSUE THROUGH A LAWSUIT, SO LIMITED INFO IS AVAILABLE. PATIENT ALLEGES THAT A LOCK ON THE BRACE FAILED, CAUSING HER TO FALL. SHE APPEARS TO HAVE SUFFERED A BROKEN HIP AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVATOR POST-OPERATIVE KNEE BRACE ITQ OSSUR AMERICAS 403015

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention