BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CTI CUSTOM PRO SPORT KNEE BRACE

    MDR report key: 1405916 · Received June 18, 2009

    Report

    Report Number
    3026585-2009-00001
    Event Type
    Injury
    Date Received
    June 18, 2009
    Date of Event
    May 26, 2009
    Report Date
    June 2, 2009
    Manufacturer
    OSSUR AMERICAS
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WE ALSO SPOKE WITH PT'S MOTHER. SHE CLAIMS THAT HER SON RE-INJURED HIS KNEE WHILE WORKING OUT IN THE GYM. SHE IS NOT CERTAIN WHAT ACTIVITY HE WAS DOING WHEN THE INJURY OCCURRED. SHE CLAIMS THAT PATIENT'S DOCTOR OK'D PT TO GO BACK TO PLAYING FOOTBALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CTI CUSTOM PRO SPORT KNEE BRACE KNEE BRACE IQI OSSUR AMERICAS B-117600010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention