BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLAR CARE KODIAK

    MDR report key: 2212925 · Received August 3, 2011

    Report

    Report Number
    2028253-2011-00046
    Event Type
    Injury
    Date Received
    August 3, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BREG, INC.
    Product Code
    ILO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BREG RECEIVED NOTICE FROM ONE OF ITS DISTRIBUTORS THAT A PT HAD RECEIVED BURNS WHILE USING A KODIAK UNIT. THE DISTRIBUTOR WAS NOTIFIED OF THIS INCIDENT VIA LEGAL SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLAR CARE KODIAK 89ILO ILO BREG, INC. KODIAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability