BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET BIOCHILL

    MDR report key: 1960437 · Received January 13, 2011

    Report

    Report Number
    2242816-2011-00004
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    January 1, 2009
    Report Date
    January 12, 2011
    Manufacturer
    EBI, LLC
    Product Code
    ILO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACKAGE INSERT CONTAINS THE FOLLOWING INFORMATION FOR THE HEALTH CARE PRACTITIONER. "A LICENSED HEALTH CARE PRACTITIONER MUST DETERMINE THE APPROPRIATE TREATMENT SETTING AND THE LENGTH OF TREATMENT FOR EACH PATIENT." "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 TO IMMEDIATELY DISCONTINUE THE COLD THERAPY TREATMENT AND NOTIFY THEIR HEALTH CARE PRACTITIONER IF THE SKIN APPEARS DISCOLORED OR FEELS NUMB." "ADVERSE EFFECTS: WHEN CRYOTHERAPY IS SELECTED AS A TREATMENT MODALITY, CLOSE MONITORING OF THE PATIENT'S RESPONSE TO CRYOTHERAPY TREATMENT IS CRITICAL. WATER CYCLING ADJUSTMENTS OR DISCONTINUATION OF THE TREATMENT MAY BE REQUIRED IF A PATIENT DEMONSTRATES A LOCALIZED HYPOTHERMIA REACTION." "LOCALIZED REACTION TO COLD: WITH A SUDDEN SHARP AND PERSISTENT DROP IN TEMPERATURE, VASOCONSTRICTION AND INCREASED VISCOSITY OF THE BLOOD IN A LOCAL AREA MAY CAUSE ISCHEMIC INJURY AND DEGENERATIVE CHANGES IN PERIPHERAL NERVES. LOCALIZED REACTIONS TO COLD MAY INCLUDE CHILBLAIN, FROSTBITE, OR IMMERSION SYNDROME. PROLONGED TISSUE HYPOXIA AND INFARCTION NECROSIS OF THE AFFECTED TISSUE MAY DEVELOP. VASCULAR INJURY AND EDEMA BECOME MORE EVIDENT AS THE TEMPERATURE RETURNS TO NORMAL. "

    Description of Event or Problem · 1

    PER PLAINTIFF'S COMPLAINT, (B)(6), "PLAINTIFF WAS INJURED REQUIRING MEDICAL TREATMENT TO HIS RIGHT KNEE ("UNDERLYING INJURY"). "THEREAFTER, PLAINTIFF BEGAN RECEIVING TREATMENT OF THE UNDERLYING INJURY FROM A QUALIFIED MEDICAL PROVIDER." "ON OR ABOUT (B)(6) 2009, PLAINTIFF WAS PRESCRIBED THE USE OF A COLD THERAPY UNIT ("CTU") "AS PART OF THE TREATMENT FOR THE UNDERLYING INJURY." "PLAINTIFF HAS SUFFERED: PAIN, SUFFERING, AND INCONVENIENCE, DISFIGUREMENT, PHYSICAL IMPAIRMENT."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability