BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLAR CARE KODIAK

    MDR report key: 2741913 · Received September 12, 2012

    Report

    Report Number
    2028253-2012-00020
    Event Type
    Malfunction
    Date Received
    September 12, 2012
    Date of Event
    July 30, 2012
    Report Date
    September 12, 2012
    Manufacturer
    BREG, INC
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    KODIAK WAS USED WITH KNEE POLAR PAD, LOT # 221275006. PAD WAS EVALUATED AS WELL AS THE UNIT AND NO PROBLEM WAS FOUND. THIS MALFUNCTION WAS REPORTED PREVIOUSLY ON MDR 2028253-2012-00023 AND MEDWATCH 1992707228-2012-008 WHICH WERE SUBMITTED PREVIOUSLY.

    Description of Event or Problem · 1

    BREG RECEIVED NOTICE FROM HOSPITAL REGARDING AN INCIDENT AT THE HOSPITAL RELATED TO A POLAR CARE KODIAK UNIT. POST SURGERY, A NURSE APPLIED A KODIAK WITH INTELLI FLO PAD TO A PATIENT'S LEFT KNEE FOLLOWING TOTAL KNEE ARTHROPLASTY. THE UNIT AND PAD WERE DISCONNECTED WHILE NOT IN USE BY PATIENT. PRIOR TO RE-APPLYING TO THE PATIENT FOR THE NEXT USE, THE PAD TUBING WAS RECONNECTED TO THE UNIT AND A LEAK WAS NOTED AT THE CONNECTION. THE UNIT AND PAD WERE BOTH REPLACED AND NO FURTHER ISSUES WERE NOTED. USER FACILITY ALSO REPORTED THE ISSUE THROUGH MEDWATCH REPORT # 1992707228-2012-009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLAR CARE KODIAK COLD THERAPY ILO BREG, INC KODIAK 221285968

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR POLAR PAD