BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI MODEL 10D

    MDR report key: 2112042 · Received June 2, 2011

    Report

    Report Number
    2242816-2011-00062
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    July 24, 2007
    Report Date
    May 4, 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: "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: 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

    BASED UPON THE ALLEGATIONS OF THE PLAINTIFF'S COMPLAINT, THE FOLLOWING WAS REPORTED: PER PLAINTIFF'S COMPLAINT, DOCKET NUMBER (B)(4), "PLAINTIFF WAS INJURED REQUIRING MEDICAL TREATMENT TO HIS LEFT ARM ("UNDERLYING INJURY"). "THEREAFTER, PLAINTIFF BEGAN RECEIVING TREATMENT OF THE UNDERLYING INJURY FROM A QUALIFIED MEDICAL PROVIDER." "ON OR ABOUT (B)(6) 2007, PLAINTIFF WAS PRESCRIBED THE USE OF A COLD THERAPY UNIT ("CTU")...AS PART OF THE TREATMENT FOR THE UNDERLYING INJURY." "ON OR ABOUT (B)(6) 2007 ("DATE OF FIRST USE"), PLAINTIFF BEGAN USING THE CTU. SINCE ENDING THE USE OF THE CTU, PLAINTIFF DISCOVERED THAT THE CTU CAUSED THE COMPLAINED OF PERSONAL INJURIES." "PLAINTIFF FIRST SUSPECTED THE INJURIES WERE CAUSED BY THE CTU ON OR AFTER (B)(6) 2010 ("DISCOVERY DATE")...THE APPROXIMATE DATE PLAINTIFF SAW A TELEVISION ADVERTISEMENT DISCUSSING THE POSSIBLE CONNECTION BETWEEN SIMILAR INJURIES AND THE COMPLAINED OF CTU" "PLAINTIFF HAS SUFFERED: PAIN, SUFFERING, AND INCONVENIENCE...DISFIGUREMENT...PHYSICAL IMPAIRMENT..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI MODEL 10D COLD THERAPY UNIT ILO EBI, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability