BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DONJOY

    MDR report key: 4193133 · Received October 21, 2014

    Report

    Report Number
    2020737-2014-00003
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 2, 2014
    Report Date
    October 20, 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

    PER 21CFR PART 803, AN MDR REPORTABLE EVENT. ORIGINAL COMPLAINT RECEIVED FROM PT THAT ALLEGED "PT REPORTS BLISTERS AND SCRATCHES TO HER LEFT LEG." QUESTIONNAIRE AND PHOTOS RECEIVED FROM CLINICIAN AND/OR PT AT A LATER TIME STATES, "THE BRACE HAS SCARED, BRUISED AND BLISTERED PT KNEE AREA FROM ALL ANGLES CAUSING TISSUE DAMAGE." DEVICE NOT RETURNED TO MANUFACTURER FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669731 DONJOY DEFIANCE ITQ DJO, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other