BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DONJOY

    MDR report key: 4281284 · Received November 18, 2014

    Report

    Report Number
    2020737-2014-00004
    Event Type
    Injury
    Date Received
    November 18, 2014
    Date of Event
    October 19, 2014
    Report Date
    November 17, 2014
    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

    COMPLAINT RECEIVED FROM PT THAT ALLEGES "CUSTOMER BROKE LOWER LEG WHILE WEARING THE BRACE. CUSTOMER HAD KNEE CAP REMOVED AND THE BRACE DID NOT SUPPORT THE KNEE. WHILE WALKING THE KNEE WENT OUT AND CAUSED THE LEG TO BUCKLE PUSHING THE LOWER BAR OF THE BRACE INTO THE LEG AND BREAKING IT." QUESTIONNAIRE NOT RECEIVED FROM CLINICIAN AND/OR PT. DEVICE NOT RETURNED TO MFR FOR EVAL. NO INDICATION DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745203 DONJOY DEFIANCE III ITQ DJO, LLC CONV DEFIANCE III

    Patients

    Seq Age Sex Outcome Treatment
    1 Other