BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLAR CARE CUBE

    MDR report key: 2912131 · Received January 11, 2013

    Report

    Report Number
    2028253-2013-00001
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    March 5, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BREG, INC.
    Product Code
    ILO
    PMA / PMN Number
    CLASS I, EXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, BREG, INC. WAS SERVED A LEGAL NOTICE FROM (B)(6) INDICATING THAT A PATIENT ALLEGES "PERSONAL INJURIES" FROM USE OF THE POLAR CARE CUBE COLD THERAPY UNIT (CTU). THE PATIENT HAD AN UNDERLYING INJURY TO THEIR LEFT KNEE AND THEIR PHYSICIAN HAD PRESCRIBED THE USE OF THE CTU. THE PATIENT BEGAN USING THE CTU ON (B)(6) 2012 AND ENDED USE ON OR ABOUT (B)(6) 2012. NO ADDITIONAL INFORMATION REGARDING THE PATIENT OR NATURE OF THE INJURIES WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18932 POLAR CARE CUBE POLAR CARE CUBE ILO BREG, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other