BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 1900262 · Received November 8, 2010

    Report

    Report Number
    2028253-2010-00030
    Event Type
    Other
    Date Received
    November 8, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BREG, INC.
    Product Code
    ILO
    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 UNK BREG MODEL COLD THERAPY UNIT, 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 UNK BREG MODEL COLD THERAPY UNIT, 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 UNK BREG MODEL COLD THERAPY UNIT, 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 UNK 89ILO ILO BREG, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other
    2 Other
    3 Other