BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DONJOY ICEMAN

    MDR report key: 1880356 · Received October 20, 2010

    Report

    Report Number
    9616086-2010-00051
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    December 15, 2009
    Report Date
    October 20, 2010
    Manufacturer
    DJ ORTHOPEDICS DE MEXICO
    Product Code
    ILO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MFR.

    Description of Event or Problem · 1

    SERVICE OF SUMMONS AND COMPLAINT WAS MFR'S FIRST NOTICE OF THIS EVENT. PLAINTIFF'S COUNSEL CLAIMS IN THE COMPLAINT THAT THE PT WAS INJURED REQUIRING MEDICAL TREATMENT TO RIGHT KNEE. HE ALLEGES THAT CRYOTHERAPY WAS APPLIED. THE COMPLAINT CONTAINS NO INFO ABOUT THE THERAPY PROTOCOL PRESCRIBED BY PLAINTIFF'S DOCTOR (E.G., DURATION OF COLD THERAPY SESSIONS AND BREAKS IN BETWEEN SAME, TEMPERATURE SETTINGS) THE BARRIER PLACED BETWEEN THE DEVICE AND THE PT'S SKIN, INSTRUCTIONS PROVIDED TO THE PT ABOUT USE OF THE DEVICE OR WHETHER THERE WERE ANY CONTRAINDICATIONS FOR COLD THERAPY. PLAINTIFF CLAIMS HE SUFFERED PERSONAL INJURIES RESULTING IN DISFIGUREMENT AND PHYSICAL IMPAIRMENT. THE COMPANY HAS BEEN UNABLE TO CONFIRM THE MFR OF OR INSPECT THE DEVICE. BECAUSE THE MATTER IS IN LITIGATION, IT HAS BEEN TURNED OVER TO OUTSIDE COUNSEL FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DONJOY ICEMAN COLD THERAPY UNIT ILO DJ ORTHOPEDICS DE MEXICO NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Disability