BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DONJOY OA NANO, MEDIAL, RT, S

    MDR report key: 8734879 · Received June 26, 2019

    Report

    Report Number
    9616086-2019-00038
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    September 21, 2018
    Report Date
    June 26, 2019
    Manufacturer
    DJO, LLC
    Product Code
    ITQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF AN AUDIT OF THE DJ ORTHOPEDICS (B)(4), FDA ISSUED A FINDING ON 13 DECEMBER 2018 THAT "PROCEDURES FOR RECEIVING, REVIEWING, AND EVALUATING COMPLAINTS BY A FORMALLY DESIGNATED UNIT HAVE NOT BEEN ADEQUATELY ESTABLISHED." THIS REPORT IS BEING SUBMITTED AS PART OF DJO'S EFFORTS TO ADDRESS THIS FINDING. DEVICE EVALUATED BY MFR: ONE OA NANO, MEDIAL, RT, S (PART NUMBER 11-1214-2, LOT NUMBER 073018) WAS RETURNED FOR EVALUATION. THE FLEXION IS HARD AND THE TOP ADJUSTMENT SCREW DOES NOT WORK, BUT IT IS NOT POSSIBLE TO DETERMINE IF THIS IS RELATED TO THE COMPLAINT REPORTED BY THE PATIENT. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THE REPORTED PRODUCT. THERE WAS NO INFORMATION IN THE DHR THAT WOULD INDICATE A PROBLEM THAT CONTRIBUTED TO THE REPORTED COMPLAINT. COMPLAINT DATA FOR SIMILAR PRODUCTS AND ISSUES GOING BACK 9 MONTHS HAS BEEN REVIEWED. THE TREND INDICATES THAT REPORTED CUSTOMER COMPLAINTS ARE WITHIN CONTROL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEG SWELLED AND TURNED BLUE WHILE WEARING THE BRACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530664 DONJOY OA NANO, MEDIAL, RT, S JOINT, KNEE, EXTERNAL BRACE ITQ DJO, LLC 11-1214-2 073018

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention