BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUTURO SPORT ADJ KNEE SUPPORT

    MDR report key: 3854908 · Received May 28, 2014

    Report

    Report Number
    2110898-2014-00033
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 19, 2014
    Report Date
    April 22, 2014
    Manufacturer
    WINNING INDUSTRIAL CO. LTD.,
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: PRODUCT WAS NOT RETURNED TO THE MANUFACTURER. RESULTS: PRODUCT WAS NOT RETURNED FOR EVALUATION. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    ON (B)(6) 2014, CUSTOMER WORE THE SPORT ADJUSTABLE KNEE BRACE. HAD THE BRACE ON FOR ABOUT 2 HOURS WHEN SHE NOTICED HER LEG WAS ITCHING, RED, SWOLLEN, AND ON THE BACK OF HER KNEE WERE BLISTER AND BUMPS. WENT TO URGENT CARE THAT NIGHT AND WAS GIVEN AN OINTMENT CALLED CLOBETASOL PROPIONATE TO USE ON HER LEG ALONG WITH A STEROID INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315110 FUTURO SPORT ADJ KNEE SUPPORT 890.3475 LIMB ORTHOSIS IQI WINNING INDUSTRIAL CO. LTD., NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other