BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUTURO HINGED KNEE BRACE

    MDR report key: 3874920 · Received June 11, 2014

    Report

    Report Number
    2110898-2014-00041
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    WINNING INDUSTRIAL CO LTD
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING NAME AND ADDRESS SHOULD BE CONSIDERED CONFIDENTIAL.

    Description of Event or Problem · 1

    HE WORE THE PRODUCT (B)(6) 2014 THROUGH (B)(6) 2014. SHE STATED HE "BROKE OUT" AND WAS MAINLY WHERE THE BRACE WAS ON HIS SKIN. HE HAD MANY RED LITTLE BUMPS ON HIS SKIN WHERE THE BRACE TOUCHED HIS SKIN THAT ITCHED. HE HAD TO GO TO URGENT CARE. THEY PRESCRIBED MEDICATION TO HIM. THEY GAVE HIM PREDNISONE AND ATARAX. THE AREA WHERE THE RED BUMPS WERE ON HIS SKIN IS BEGINNING TO CLEAR UP NOW AND IS LOOKING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343864 FUTURO HINGED KNEE BRACE 890.3475 LIMB ORTHOSIS IQI WINNING INDUSTRIAL CO LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK