BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLAR CARE 300

    MDR report key: 1999194 · Received February 9, 2011

    Report

    Report Number
    2028253-2011-00001
    Event Type
    Other
    Date Received
    February 9, 2011
    Report Date
    February 1, 2011
    Manufacturer
    BREG, INC
    Product Code
    ILO
    PMA / PMN Number
    K963596
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BREG REC'D LEGAL NOTICE OF FILED LAWSUITS EACH WITH MULTIPLE COMPLAINANTS, 24 IN TOTAL, 3 FOR POLAR CARE 300, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND RPTR HAS NO KNOWLEDGE IF THIS TERM MEETS THE REQUIREMENTS OF SERIOUS INJURY AS DEFINED BY CURRENT FDA GUIDELINES. BREG HAS REVIEWED INTERNAL COMPLAINT FILES AND MAUDE DATABASE AND FINDS NO RECORD OF PREVIOUS NOTICE OF THESE "PERSONAL INJURY" CLAIMS. FIRST NOTIFICATION WAS SERVICE OF LAWSUIT ON (B)(6) 2011.

    Description of Event or Problem · 2

    BREG REC'D LEGAL NOTICE OF FILED LAWSUITS EACH WITH MULTIPLE COMPLAINANTS, 24 IN TOTAL, 3 FOR POLAR CARE 300, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND RPTR HAS NO KNOWLEDGE IF THIS TERM MEETS THE REQUIREMENTS OF SERIOUS INJURY AS DEFINED BY CURRENT FDA GUIDELINES. BREG HAS REVIEWED INTERNAL COMPLAINT FILES AND MAUDE DATABASE AND FINDS NO RECORD OF PREVIOUS NOTICE OF THESE "PERSONAL INJURY" CLAIMS. FIRST NOTIFICATION WAS SERVICE OF LAWSUIT ON (B)(6) 2011.

    Description of Event or Problem · 3

    BREG REC'D LEGAL NOTICE OF FILED LAWSUITS EACH WITH MULTIPLE COMPLAINANTS, 24 IN TOTAL, 3 FOR POLAR CARE 300, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND RPTR HAS NO KNOWLEDGE IF THIS TERM MEETS THE REQUIREMENTS OF SERIOUS INJURY AS DEFINED BY CURRENT FDA GUIDELINES. BREG HAS REVIEWED INTERNAL COMPLAINT FILES AND MAUDE DATABASE AND FINDS NO RECORD OF PREVIOUS NOTICE OF THESE "PERSONAL INJURY" CLAIMS. FIRST NOTIFICATION WAS SERVICE OF LAWSUIT ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLAR CARE 300 89ILO ILO BREG, INC PC300 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other
    2 Other
    3 Other