BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULLFORCE KNEE BRACE

    MDR report key: 1842632 · Received September 1, 2010

    Report

    Report Number
    9616086-2010-00022
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Report Date
    August 3, 2010
    Manufacturer
    DJ ORTHOPEDICS DE MEXICO
    Product Code
    ITQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED HE WAS WEARING HIS FULLFORCE KNEE LIGAMENT BRACING AND THE BRACE BROKE WHEN HE WAS PLAYING SOCCER IN THE BACKYARD, AND HE FELL AND STATES THAT NOW HE'S GOING TO HAVE AN MRI TO DETERMINE WHAT THE DIAGNOSIS IS. POSSIBLE MENISCUS TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FULLFORCE KNEE BRACE FULLFORCE, ACL, STD, CALF, RT, L ITQ DJ ORTHOPEDICS DE MEXICO 11-0258-4

    Patients

    Seq Age Sex Outcome Treatment
    1