BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET BIOCHILL

    MDR report key: 2642968 · Received June 29, 2012

    Report

    Report Number
    MW5025996
    Event Type
    Injury
    Date Received
    June 29, 2012
    Date of Event
    May 2, 2010
    Report Date
    June 29, 2012
    Manufacturer
    EBI INC/BIOMET INC
    Product Code
    ILO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT (B)(6) 2010 OUTPATIENT SURGERY WITH FUSION AND DEEP PERONEAL NERVE BURIAL OF RIGHT FOOT. PT WAS PROVIDED COLD THERAPY UNIT KNOWN AS "BIOMET BIOCHILL" FROM EBI, LLC PRIOR TO DISCHARGE. ON (B)(6) 2010, PT NOTICED SIGNIFICANT PAIN AND CHILLS, PRESENTED TO LOCAL EMERGENCY DEPT WHERE "FROSTBITE" AND ISCHEMIA WAS OBSERVED AND APPEARANCE WAS CONSIDERED "ISCHEMIA SECONDARY TO EITHER COMPARTMENT SYNDROME OR THERMAL-INDUCED ISCHEMIA." ATTEMPTS WERE MADE TO REVASCULARIZE THE FOOT WITH THROMBOLYTIC THERAPY, ANGIOPLASTY, INFUSION OF A VASODILATOR. EVENTUALLY, DUE TO DRY GANGRENE, PT'S TOES, 1 - 4, AND PART OF FOOT HAD TO BE AMPUTATED. PT CONTINUES TO SUFFER BURNING, SHARP, AND STABBING PAIN WORSE WITH STANDING, WALKING, OR TOUCH. SHE HAS PERMANENT PHYSICAL IMPAIRMENT AND DISFIGUREMENT. THE USE OF THE BIOCHILL WAS INAPPROPRIATE AND/OR IMPROPERLY PLACED; THE PRODUCT INSTRUCTIONS AND INSTRUCTIONS TO THE PT WERE INADEQUATE AND/OR INCOMPLETE; WARNINGS AND INFO OF "ADVERSE EFFECTS" OF THE CRYOTHERAPY WERE INSUFFICIENT; THE HEALTH CARE PROVIDERS OF THE DEVICE FAILED TO PROPERLY PLACE THE DEVICE, INSTRUCT THE PT, AND/OR MONITOR FOR SAFE AND PROPER USE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| S