BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREG POLAR CARE KODIAK

    MDR report key: 1336429 · Received March 9, 2009

    Report

    Report Number
    1336429
    Event Type
    Injury
    Date Received
    March 9, 2009
    Date of Event
    October 6, 2008
    Report Date
    November 24, 2008
    Manufacturer
    BREG, INC.
    Product Code
    ILO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INCIDENT FIRST REPORTED TO THE HOSP ON 10/23/2008, BY THE OFFICE STAFF OF ATTENDING PHYSICIAN. REPORTED THAT PT HAD UNDERGONE AN ACL REPAIR OF THE RIGHT KNEE IN 2008 AND HAD POST-OP COMPLICATIONS OF NECROTIC TISSUE. PT SENT TO A PLASTIC SURGEON FOR CONSULT AND WAS DIAGNOSED WITH FROSTBITE THERMAL BURN, NECESSITATING A SKIN GRAFT TO RIGHT KNEE. PHYSICIANS BELIEVE THAT THE ISCHEMIC INJURY MAY HAVE POSSIBLY OCCURRED DUE TO AN IDOSYNCRATIC REACTION TO THE LOCAL ANESTHETIC WITH EPINEPHRINE AND THE USE OF THE POLARCARE KODIAK BREG ICE CUFF. SUPPOSEDLY THE ICE PUMP HAS AN INTERNAL THERMOSTAT TO PREVENT CIRCULATING WATER TEMPERATURE LOWER THAN 45 DEGREES F, BUT IT DOES NOT HAVE AN OPENING OVER THE PATELLA. THE PT'S FAMILY STATES THEY MEASURED THE TEMPERATURE OF THE WATER AND ALLEGEDLY IT WAS ALMOST AT FREEZING, 32 DEGREES F. PT CURRENTLY PROGRESSING WELL WITH PHYSICAL THERAPY. NO INFECTION. GRAFT AREAS NOW HEALED BUT STILL HAS AREA WHERE THERE APPEARS TO BE A DIVOT IN THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREG POLAR CARE KODIAK BREG ICE CUFF ILO BREG, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention