BEUDAMED
    FDA Adverse Event Other Summary report: N

    HANGER SE , ACL, RT, XL, BLK/GREY

    MDR report key: 2492418 · Received March 12, 2012

    Report

    Report Number
    9616086-2012-00015
    Event Type
    Other
    Date Received
    March 12, 2012
    Report Date
    March 12, 2012
    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

    WHILE WEARING BRACE CUSTOMER FIRST NOTICED IRRITATION, THAT QUICKLY TURNED INTO SEVERE RASH THAT INITIATED WITH THE ANTI MIGRATION BAND BEHIND THE KNEE AND SPREAD THRU THE ENTIRE LEG DOWN TO CALF AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANGER SE , ACL, RT, XL, BLK/GREY ITQ DJO LLC 11-1980-5-06160

    Patients

    Seq Age Sex Outcome Treatment
    1 Other