BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT PRO-THERAPY KNEE BRACE AND HOT PACK

    MDR report key: 1532793 · Received November 16, 2009

    Report

    Report Number
    1022556-2009-00204
    Event Type
    Other
    Date Received
    November 16, 2009
    Report Date
    October 13, 2006
    Manufacturer
    CHATTEM, INC.
    Product Code
    OMW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOR (B) (4) - SINCE THIS IS A DISPOSABLE SINGLE-USE DEVICE, THE PRODUCT IS UNAVAILABLE FOR EVALUATION AND ANALYSIS. THIS REPORT IS BELOW THE THRESHOLD OF THE FDA'S REQUIREMENTS FOR MANDATORY REPORTING OF ADVERSE EVENTS INVOLVING MEDICAL DEVICES AS THERE IS NO EVIDENCE THAT USE OF THE PRODUCT RESULTED IN SERIOUS ADVERSE HEALTH CONSEQUENCES. ACCORDINGLY, THIS MDR IS BEING SUBMITTED AS VOLUNTARY AND PROACTIVE MEASURE BY THE MFR TO ENHANCE PRODUCT SAFETY AND PHARMACOVIGILANCE.

    Description of Event or Problem · 1

    REPORT THAT PRODUCT PRODUCED WELTS ON LEG OF CONSUMER. NO FURTHER DETAILS AVAILABLE. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT PRO-THERAPY KNEE BRACE AND HOT PACK IQI AND IMD OMW CHATTEM, INC. 1810A 06B109

    Patients

    Seq Age Sex Outcome Treatment
    1 Other