BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBICE CONTROLLED COLD THERAPY

    MDR report key: 2950895 · Received February 8, 2013

    Report

    Report Number
    0002242816-2013-00007
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 14, 2013
    Manufacturer
    EBI, LLC.
    Product Code
    ILO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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." PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    PER PLAINTIFF'S COMPLAINT, CIVIL ACTION NO. (B)(4) (B)(6) "... WAS INJURED REQUIRING MEDICAL TREATMENT TO HER LEFT FOOT ("UNDERLYING INJURY")." THEREAFTER, PLAINTIFF BEGAN RECEIVING TREATMENT OF THE UNDERLYING INJURY FROM A QUALIFIED MEDICAL PROVIDER." " ON OR ABOUT (B)(6) 2008, PLAINTIFF WAS PRESCRIBED THE USE OF THE CTU...AS PART OF THE TREATMENT FOR THE UNDERLYING INJURY." " ON OR ABOUT (B)(6) 2008 ("DATE OF FIRST USE"), PLAINTIFF BEGAN USING THE CTU. SINCE ENDING THE USE OF CTU, PLAINTIFF DISCOVERED THAT THE CTU CAUSED THE COMPLAINED OF PERSONAL INJURIES. PLAINTIFF FIRST SUSPECTED THE INJURIES CAUSED BY THE CTU ON OR AFTER (B)(6) 2010 ("DISCOVERY DATE")... THE DATE THE 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..." THE ALLEGATIONS OF THE COMPLAINT ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55143 EBICE CONTROLLED COLD THERAPY SYSTEM ASSY. W/O PAD 10D ILO EBI, LLC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability