BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRCAST CRYO/CAST THERAPY UNIT

    MDR report key: 2030782 · Received March 21, 2011

    Report

    Report Number
    9616086-2011-00013
    Event Type
    Injury
    Date Received
    March 21, 2011
    Date of Event
    October 31, 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 (B)(6) AND COMPLAINT WAS MFR'S FIRST NOTICE OF THIS EVENT. PLAINTIFF'S COUNSEL CLAIMS IN THE COMPLAINT THAT THE PT SUFFERED A PERSONAL INJURY FOLLOWING THE APPLICATION OF (B)(6) FOR THE TREATMENT OF AN UNDERLYING RIGHT KNEE INJURY. THERE IS NO INFO IN THE COMPLAINT ABOUT THE PERSONAL INJURY OR THE TEMPERATURE AT WHICH THE DEVICE WAS SET. 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 AIRCAST CRYO/CAST THERAPY UNIT WATER CIRCULATING HOT OR COLD PACK ILO DJ ORTHOPEDICS DE MEXICO 1100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other