BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICEMAN THERAPY UNIT

    MDR report key: 2033562 · Received March 21, 2011

    Report

    Report Number
    9616086-2011-00005
    Event Type
    Injury
    Date Received
    March 21, 2011
    Date of Event
    August 1, 2010
    Report Date
    March 14, 2011
    Manufacturer
    DJ ORTHOPEDICS DE MEXICO
    Product Code
    ILO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SERVICE OF SUMMONS AND COMPLAINT WAS MANUFACTURER'S FIRST NOTICE OF THIS EVENT. PLAINTIFF'S COUNSEL CLAIMS IN THE COMPLAINT THAT THE PATIENT SUFFERED PAIN AT THE SURGICAL SITE IN HIS RIGHT LEG AND FOOT AND WAS NOT SURE IF THE APPLICATION OF CRYOTHERAPY (ICEMAN) CAUSED THE PAIN. THERE IS NO INFORMATION IN THE COMPLAINT ABOUT THE PERSONAL INJURY OR THE TEMPERATURE AT WHICH THE DEVICE WAS SET. THE COMPANY HAS BEEN UNABLE TO CONFIRM THE MANUFACTURER 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 ICEMAN THERAPY UNIT WATER CIRCULATING HOT OR COLD PACK ILO DJ ORTHOPEDICS DE MEXICO 1100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other