BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLAR CARE 300

    MDR report key: 1900264 · Received November 8, 2010

    Report

    Report Number
    2028253-2010-00028
    Event Type
    Other
    Date Received
    November 8, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BREG, INC.
    Product Code
    ILO
    PMA / PMN Number
    K963596
    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 300, 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.

    Description of Event or Problem · 10

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 11

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 12

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 13

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 14

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 15

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 16

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 17

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 18

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 19

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 2

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 20

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 21

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 22

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 23

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 24

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 25

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 26

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 27

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 28

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 29

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 3

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 30

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 31

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 32

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 33

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 34

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 4

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 5

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 6

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 7

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 8

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Description of Event or Problem · 9

    BREG REC'D LEGAL NOTICE OF 2 FIELD LAWSUITS WITH USE OF POLAR CARE 300, 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLAR CARE 300 89ILO ILO BREG, INC. POLAR CARE 300 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
    18 Other
    19 Other
    2 Other
    20 Other
    21 Other
    22 Other
    23 Other
    24 Other
    25 Other
    26 Other
    27 Other
    28 Other
    29 Other
    3 Other
    30 Other
    31 Other
    32 Other
    33 Other
    34 Other
    4 Other
    5 Other
    6 Other
    7 Other
    8 Other
    9 Other