BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBICE

    MDR report key: 1960459 · Received January 13, 2011

    Report

    Report Number
    2242816-2011-00003
    Event Type
    Injury
    Date Received
    January 13, 2011
    Report Date
    December 16, 2010
    Manufacturer
    EBI, LLC
    Product Code
    ILO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG AND LOT NUMBERS WERE NOT PROVIDED. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE PACKAGE INSERT CONTAINS THE FOLLOWING INFORMATION FOR THE HEALTH CARE PRACTITIONER. "ADVERSE EFFECTS: WHEN CRYOTHERAPY IS SELECTED AS A TREATMENT MODALITY, CLOSE MONITORING OF THE PATIENTS RESPONSE TO CRYOTHERAPY TREATMENT IS CRITICAL." "LOCALIZED REACTION TO COLD: LOCALIZED REACTIONS TO COLD MAY INCLUDE CHILBLAIN, FROSTBITE, OR IMMERSION SYNDROME." "SPECIAL CONSIDERATIONS: 1.) INDIVIDUAL SENSITIVITY TO A CRYOTHERAPY APPLICATION VARIES. IT IS IMPORTANT TO PERIODICALLY CHECK THE COLOR AND SENSITIVITY OF THE SKIN AT THE TREATMENT SITE. THE PATIENT SHOULD BE INSTRUCTED THAT IF THE SKIN APPEARS DISCOLORED OR FEELS NUMB, IMMEDIATELY DISCONTINUE THE COLD THERAPY TREATMENT AND NOTIFY YOUR HEALTH CARE PRACTITIONER." "WARNINGS: THE LICENSED HEALTH CARE PRACTITIONER DETERMINES THE APPROPRIATE TREATMENT FOR EACH PATIENT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PHYSICIAN ALLEGES PATIENT EXPERIENCED FROSTBITE WITH THE COLD THERAPY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBICE COLD THERAPY UNIT ILO EBI, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other