BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAME READY SYSTEM

    MDR report key: 4951509 · Received July 28, 2015

    Report

    Report Number
    2954777-2015-00002
    Event Type
    Injury
    Date Received
    July 28, 2015
    Date of Event
    September 10, 2013
    Report Date
    July 24, 2015
    Manufacturer
    COOLSYSTEMS, INC.
    Product Code
    IRP
    PMA / PMN Number
    K071050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGED EVENT CAME TO COOLSYSTEMS, INC. ATTENTION VIA SERVICE OF A SUMMONS AND COMPLAINT FOR DAMAGES FILED WITH THE SUPERIOR COURT OF (B)(6), COUNTY OF (B)(6). THE COMPLAINT FOR DAMAGES WAS FILED ALMOST 2 YEARS AFTER THE ALLEGED EVENT. A COMPLAINT WAS NEVER REPORTED TO COOLSYSTEMS, INC., AND THE GAME READY SYSTEM INVOLVED IN THE EVENT HAS NOT BEEN IDENTIFIED. THUS, IT CANNOT BE DETERMINED WHAT ITS PERFORMANCE HISTORY WAS OR WHICH DEVICE TO RETURN FOR EVALUATION. THIS IS WHY THE EVALUATION CODES WERE CHOSEN.

    Description of Event or Problem · 1

    SERVICE OF SUMMONS ON 07/24/2015 WAS THE MANUFACTURER'S FIRST NOTICE OF THIS EVENT. THE PLAINTIFF WAS PRESCRIBED A GAME READY SYSTEM ON (B)(6) 2013 BY HER PHYSICIAN AS POSTOPERATIVE TREATMENT FOLLOWING THE REMOVAL OF A BUNION ON HER LEFT FOOT. DURING A FOLLOW UP VISIT ON 09/10/2013, THE PLAINTIFF COMPLAINED OF SOME DISCOLORATION ON HER FOOT, RECEIVED TREATMENT, AND DISCONTINUED THE USE OF THE GAME READY SYSTEM PER HER PHYSICIAN'S RECOMMENDATION. THE CONDITION OF THE FOOT WORSENED, EVENTUALLY RESULTING IN GANGRENE, AND ULTIMATELY A PARTIAL AMPUTATION OF HER FOOT. THE COMPLAINT DOES NOT CONTAIN INFORMATION ABOUT THE THERAPY PROTOCOL PRESCRIBED BY THE PLAINTIFF'S PHYSICIAN (E.G. DURATION OF COLD THERAPY SESSIONS AND BREAKS IN BETWEEN SAME, TEMPERATURE SETTING, AND COMPRESSION LEVEL SETTING), THE BARRIER PLACED BETWEEN THE WRAP (APPLIED ACCESSORY) AND THE PATIENT'S SKIN, INSTRUCTIONS FOR USE PROVIDED TO THE PLAINTIFF ABOUT THE DEVICE. BECAUSE THE MATTER IS IN LITIGATION, IT HAS BEEN TURNED OVER TO THE OUTSIDE COUNSEL FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490707 GAME READY SYSTEM COLD- AND INTERMITTENT COMPRESSION IRP COOLSYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability