BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARMOR

    MDR report key: 2445511 · Received February 6, 2012

    Report

    Report Number
    9616086-2012-00009
    Event Type
    Other
    Date Received
    February 6, 2012
    Date of Event
    December 19, 2011
    Report Date
    February 6, 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

    PT WAS PLAYING BASKETBALL AND AFTER MAKING A VERTICAL JUMP INJURED HIS KNEE THAT PRODUCED SWELLING. PT WAS TAKEN TO EMERGENCY ROOM, SURGERY WAS REQUIRED ON (B)(6)-2011. NO VISIBLE DAMAGE TO BRACE AT TIME OF INJURY PER REPORTER. BRACE HAS NOT BEEN RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARMOR ARMOR BRACE WITH A FOURCEPOINT HINGE ITQ DJO LLC 11-1441-3

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention