BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 2143124 · Received June 20, 2011

    Report

    Report Number
    2028253-2011-00039
    Event Type
    Other
    Date Received
    June 20, 2011
    Report Date
    June 17, 2011
    Manufacturer
    BREG, INC
    Product Code
    ILO
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BREG RECEIVED LEGAL NOTICE OF FILED LAWSUITS EACH WITH MULTIPLE COMPLAINANTS, 17 IN TOTAL, 1 FOR 'UNK COLD THERAPY' 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 NOTIFICATION WAS SERVICE OF LAWSUIT ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN 89ILO ILO BREG, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other