BEUDAMED
    FDA Adverse Event Summary report: N

    BREG POLAR CARE GLACIER

    MDR report key: 5066107 · Received September 9, 2015

    Report

    Report Number
    2028253-2015-00006
    Date Received
    September 9, 2015
    Date of Event
    February 9, 2015
    Report Date
    September 8, 2015
    Manufacturer
    BREG, INC.
    Product Code
    ILO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. BREG HAS REVIEWED INTERNAL COMPLAINT FILES AND FINDS NO RECORD OF THIS INCIDENT PREVIOUSLY BEING REPORTED. THIS IS THE FIRST NOTIFICATION RECEIVED FOR THIS INCIDENT. DEVICE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    BREG RECEIVED NOTIFICATION THROUGH FDAS MEDWATCH PROGRAM OF A PATIENT WHO ALLEGEDLY EXPERIENCED UNEXPECTED REDNESS, SWELLING, AND DELAYED WOUND HEALING FOLLOWING TOTAL KNEE ARTHOPLASTY AND THE APPLICATION OF COLD THERAPY. THE MEDWATCH REPORT REFERENCES THE POLAR CARE GLACIER AS THE COLD THERAPY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594520 BREG POLAR CARE GLACIER POLAR CARE GLACIER ILO BREG, INC. 10901

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization