BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DONJOY

    MDR report key: 5993461 · Received October 3, 2016

    Report

    Report Number
    2020737-2016-00013
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    September 15, 2016
    Report Date
    October 3, 2016
    Manufacturer
    DJO, LLC
    Product Code
    ITQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED THAT ALLEGES "HE WAS RUNNING WHEN THE BRACE BROKE WITH CAUSED HIM TO FALL. AS A RESULT HE TORE HIS ACL AND A LIGAMENT IN HIS HIP AS WELL". QUESTIONNAIRE NOT RECEIVED FROM CUSTOMER OR CLINICIAN. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645754 DONJOY DEFIANCE III FP ITQ DJO, LLC DEFIANCE III FP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other