BEUDAMED
    FDA Adverse Event Other Summary report: N

    CTI OFF-THE-SHELF PRO SPORT RIGHT & LEFT BRACE

    MDR report key: 1542864 · Received November 18, 2009

    Report

    Report Number
    3026585-2009-00004
    Event Type
    Other
    Date Received
    November 18, 2009
    Date of Event
    September 26, 2009
    Report Date
    November 17, 2009
    Manufacturer
    OSSUR AMERICAS
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS NOT FAULTY OR DEFECTIVE, PT WAS USING PRODUCT DURING EXTREME SPORTS ACTIVITY, LANDED INCORRECTLY WHILE JUMPING FROM A WAKE AND FEARED INJURY. WHILE NO INJURY WAS IDENTIFIED, WE DECIDED TO FILE A MEDWATCH REPORT.

    Description of Event or Problem · 1

    PT WAS WEARING OUR KNEE BRACES WHILE WAKEBOARDING. PT STATES HE JUMPED OFF AND LANDED WRONG FROM JUMPING THE WAKE. PT WENT TO DOCTOR FOR MRI, BUT NO INJURIES WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CTI OFF-THE-SHELF PRO SPORT RIGHT & LEFT BRACE CTI OTS BRACE IQI OSSUR AMERICAS B-239500113

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention