BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRCAST CRYOCUFF

    MDR report key: 3121946 · Received May 15, 2013

    Report

    Report Number
    9616086-2013-00010
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    January 14, 2011
    Report Date
    May 15, 2013
    Manufacturer
    DJO, LLC
    Product Code
    ILO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER LAWSUIT DOCUMENTATION RECEIVED; AFTER APPROXIMATELY 80 HOURS OF CONTINUOUS USE OF THE "ICE BOOT" PER POST SURGICAL DIRECTIONS PT REPORTED TO EMERGENCY ROOM WITH SWOLLEN LEG, ANKLE AND FOOT WERE WHITE WITH RED SPOTS. PT DIAGNOSED AT EMERGENCY ROOM WITH "COMPARTMENT SYNDROME R FOOT" AND ACUTE SEVERE INTRACTABLE PAIN. EMERGENCY FASCIOTOMY PERFORMED ON THREE LOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215450 AIRCAST CRYOCUFF CRYOCUFF COOLER ILO DJO, LLC 10A

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability