BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DONJOY FULLFORCE,ACL,SHRT CF,LT,M

    MDR report key: 10128120 · Received June 8, 2020

    Report

    Report Number
    3012446970-2020-00019
    Event Type
    Injury
    Date Received
    June 8, 2020
    Date of Event
    January 20, 2020
    Report Date
    June 3, 2020
    Manufacturer
    DJO LLC.
    Product Code
    ITQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RETURNED FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS "RUNNING ON THE FIELD AND PIVOTED TO MAKE A TURN DURING A LACROSSE TRYOUT PRACTICE WHILE WEARING THE DONJOY KNEE BRACE ON J(B)(6) 2020." THIS INJURY RESULTED IN A COMPLETE RE-TEAR OF THE SAME KNEE (LEFT) THAT THE PATIENT HAD PREVIOUSLY TORN. THIS INJURY RESULTED IN A SURGICAL REPAIR PERFORMED ON (B)(6) 2020. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF THE DEVICE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591215 DONJOY FULLFORCE,ACL,SHRT CF,LT,M JOINT, KNEE, EXTERNAL BRACE ITQ DJO LLC. 11-3221-3

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention