BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTELECT 2CH COMBO

    MDR report key: 1012379 · Received March 7, 2008

    Report

    Report Number
    1022819-2008-00075
    Event Type
    Other
    Date Received
    March 7, 2008
    Date of Event
    February 18, 2008
    Report Date
    March 6, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING RETURN AND EVALUATION OF DEVICE.

    Description of Event or Problem · 1

    ULTRASOUND FEATURE IS OVERHEATING DURING PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELECT 2CH COMBO POWER MUSCLE STIMULATOR IPF CHATTANOOGA GROUP 2760

    Patients

    Seq Age Sex Outcome Treatment
    1 Other