BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLAR CARE 500

    MDR report key: 1900265 · Received November 8, 2010

    Report

    Report Number
    2028253-2010-00027
    Event Type
    Other
    Date Received
    November 8, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BREG, INC.
    Product Code
    ILO
    PMA / PMN Number
    K913729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 500, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND REPORTER 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 NOTIFICATIONS WAS SERVICE OF LAWSUITS ON (B)(6) 2010 AND (B)(6) 2010.

    Description of Event or Problem · 10

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 500, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND REPORTER 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 NOTIFICATIONS WAS SERVICE OF LAWSUITS ON (B)(6) 2010 AND (B)(6) 2010.

    Description of Event or Problem · 11

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 500, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND REPORTER 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 NOTIFICATIONS WAS SERVICE OF LAWSUITS ON (B)(6) 2010 AND (B)(6) 2010.

    Description of Event or Problem · 12

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 500, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND REPORTER 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 NOTIFICATIONS WAS SERVICE OF LAWSUITS ON (B)(6) 2010 AND (B)(6) 2010.

    Description of Event or Problem · 13

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 500, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND REPORTER 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 NOTIFICATIONS WAS SERVICE OF LAWSUITS ON (B)(6) 2010 AND (B)(6) 2010.

    Description of Event or Problem · 14

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 500, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND REPORTER 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 NOTIFICATIONS WAS SERVICE OF LAWSUITS ON (B)(6) 2010 AND (B)(6) 2010.

    Description of Event or Problem · 15

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 500, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND REPORTER 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 NOTIFICATIONS WAS SERVICE OF LAWSUITS ON (B)(6) 2010 AND (B)(6) 2010.

    Description of Event or Problem · 16

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 500, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND REPORTER 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 NOTIFICATIONS WAS SERVICE OF LAWSUITS ON (B)(6) 2010 AND (B)(6) 2010.

    Description of Event or Problem · 17

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 500, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND REPORTER 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 NOTIFICATIONS WAS SERVICE OF LAWSUITS ON (B)(6) 2010 AND (B)(6) 2010.

    Description of Event or Problem · 2

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 500, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND REPORTER 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 NOTIFICATIONS WAS SERVICE OF LAWSUITS ON (B)(6) 2010 AND (B)(6) 2010.

    Description of Event or Problem · 3

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 500, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND REPORTER 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 NOTIFICATIONS WAS SERVICE OF LAWSUITS ON (B)(6) 2010 AND (B)(6) 2010.

    Description of Event or Problem · 4

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 500, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND REPORTER 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 NOTIFICATIONS WAS SERVICE OF LAWSUITS ON (B)(6) 2010 AND (B)(6) 2010.

    Description of Event or Problem · 5

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 500, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND REPORTER 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 NOTIFICATIONS WAS SERVICE OF LAWSUITS ON (B)(6) 2010 AND (B)(6) 2010.

    Description of Event or Problem · 6

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 500, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND REPORTER 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 NOTIFICATIONS WAS SERVICE OF LAWSUITS ON (B)(6) 2010 AND (B)(6) 2010.

    Description of Event or Problem · 7

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 500, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND REPORTER 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 NOTIFICATIONS WAS SERVICE OF LAWSUITS ON (B)(6) 2010 AND (B)(6) 2010.

    Description of Event or Problem · 8

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 500, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND REPORTER 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 NOTIFICATIONS WAS SERVICE OF LAWSUITS ON (B)(6) 2010 AND (B)(6) 2010.

    Description of Event or Problem · 9

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 500, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND REPORTER 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 NOTIFICATIONS WAS SERVICE OF LAWSUITS ON (B)(6) 2010 AND (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLAR CARE 500 89ILO ILO BREG, INC. POLAR CARE 500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other
    10 Other
    11 Other
    12 Other
    13 Other
    14 Other
    15 Other
    16 Other
    17 Other
    2 Other
    3 Other
    4 Other
    5 Other
    6 Other
    7 Other
    8 Other
    9 Other