BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMALE FOURCE OTS, RIGHT XL

    MDR report key: 2419394 · Received January 11, 2012

    Report

    Report Number
    2020737-2012-00016
    Event Type
    Injury
    Date Received
    January 11, 2012
    Date of Event
    August 25, 2011
    Report Date
    January 4, 2012
    Manufacturer
    DJO, LLC
    Product Code
    ITQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPAIRED ACL GRAFT WAS RE-INJURED WHILE PLAYING SOFTBALL AND WEARING THE SUPPORT BRACE. THE RE-INJURY OCCURRED ON (B)(6) 2011. THE REPAIR TO THE RE-INJURED ACL TEAR WAS PERFORMED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMALE FOURCE OTS, RIGHT XL RIGID BRACE ITQ DJO, LLC 11-1430-5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other