BEUDAMED
    FDA Adverse Event Summary report: N

    ACE MOISTURE CONTROL KNEE SUPPORT

    MDR report key: 4223952 · Received October 31, 2014

    Report

    Report Number
    2110898-2014-00075
    Date Received
    October 31, 2014
    Date of Event
    October 31, 2014
    Report Date
    October 31, 2014
    Manufacturer
    WINNING INDUSTRIAL CO. LTD
    Product Code
    LFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    CUSTOMER PURCHASED THE KNEE BRACE AND WORE IT OVER HER JEANS AND WAS FINE. SHE LATER STARTED WEARING THE BRACE AGAINST HER SKIN. ONCE SHE STARTED WEARING THE BRACE AGAINST HER SKIN, THE SKIN REACTED WITH REDNESS AND BLISTERS. THE CONDITION WAS TREATED WITH PREDNISONE WHICH HELPED RELIEVE THE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699187 ACE MOISTURE CONTROL KNEE SUPPORT 890.3475 LIM ORTHOSIS LFL WINNING INDUSTRIAL CO. LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK