BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVATOR DLX+ COOL

    MDR report key: 3787016 · Received April 24, 2014

    Report

    Report Number
    2085446-2014-00002
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 23, 2014
    Manufacturer
    L&L INTERNATIONAL CO LTD
    Product Code
    ITQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS WALKING DOWN SOME OUTSIDE STEPS WITH HIS ARM AROUND HIS FRIEND WHILE HE WAS WEARING AN INNOVATOR DLX+ COOL KNEE BRACE WHICH WAS LOCKED IN A 30 DEGREES POSITION. HIS FRIEND LOST HIS BALANCE AND FELL CAUSING (B)(6) TO FALL ON TOP OF HIS FRIEND. (B)(6) HIT HIS KNEE ON THE PAVEMENT AND BROKE HIS LEG AND KNEE CAP. (B)(6) NOTICED AFTER THE FALL THAT THE BRACE WAS NO LONGER IN THE LOCKED 30 DEGREES POSITION. PT WENT TO THE HOSPITAL VIA AMBULANCE AND EMERGENCY SURGERY WAS PERFORMED. PT CLAIMS HE WILL NO LONGER HAVE FULL RANGE OF MOTION IN HIS KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249830 INNOVATOR DLX+ COOL JOINT, KNEEE, EXTERNAL, BRACE ITQ L&L INTERNATIONAL CO LTD 423100+

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention