BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBICE COLD THERAPY

    MDR report key: 1307327 · Received February 6, 2009

    Report

    Report Number
    2242816-2009-00002
    Event Type
    Injury
    Date Received
    February 6, 2009
    Date of Event
    November 7, 2006
    Report Date
    January 13, 2009
    Manufacturer
    EBI, L.P.
    Product Code
    ILO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE WERE NO DISCREPANCIES RECORDED. THE DEVICE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE PACKAGE INSERT WAS REVIEWED. THE PATIENT TREATMENT IS DETERMINED BY THE HEALTH CARE PRACTITIONER. CLOSE MONITORING OF THE PATIENT'S RESPONSE TO THE CRYOTHERAPY TREATMENT IS CRITICAL. LOCAL REACTIONS TO COLD MAY INCLUDE CHILBLAIN, FROSTBITE OR IMMERSION SYNDROME.

    Description of Event or Problem · 1

    AT POST OPERATIVE VISIT, THE SURGEON OBSERVED THE PATIENT'S RIGHT FOOT WAS WITH ONSET OF PAIN, DECREASED SENSATION DECREASED PERFUSIONS AND NO PEDAL PULSES. PATIENT OUTCOME: THE PATIENT WAS DIAGNOSED WITH SEQUELAE OF COLD INJURY AND PROBABLE FROSTBITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBICE COLD THERAPY ILO EBI, L.P. 10D 280842

    Patients

    Seq Age Sex Outcome Treatment
    1 Other