BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELECT ADVANCED

    MDR report key: 1242575 · Received November 21, 2008

    Report

    Report Number
    1022819-2008-00316
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 24, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS FOR EXPORT ONLY. AWAITING RETURN AND EVALUATION OF THE DEVICE.

    Description of Event or Problem · 1

    PATIENT RECEIVED A SKIN BURN AND POTENTIAL BRUISING AFTER BEING TREATED WITH ELECTROTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELECT ADVANCED IPF, IMG,GZJ, HCC,GZI IPF CHATTANOOGA GROUP 2772MC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention