BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREG POLAR CARE KODIAK

    MDR report key: 5066109 · Received September 9, 2015

    Report

    Report Number
    2028253-2015-00007
    Event Type
    Injury
    Date Received
    September 9, 2015
    Report Date
    September 9, 2015
    Manufacturer
    BREG, INC.
    Product Code
    ILO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED AND TESTED, MET ALL FUNCTIONAL REQUIREMENTS. NO EVIDENCE OF DAMAGE OR MALFUNCTION. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    BREG RECEIVED A REPORT OF ALLEGED FROSTBITE AFTER USING A POLAR CARE KODIAK COLD THERAPY DEVICE. THE PATIENT RECEIVED COLD THERAPY TREATMENT TWO DAYS AFTER UNDERGOING ACL SURGERY THEN AGAIN 2 WEEKS AFTER SURGERY DUE TO A HEMATOMA ON HIS LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594652 BREG POLAR CARE KODIAK POLAR CARE KODIAK ILO BREG, INC. 10607

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention