BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELECT CB

    MDR report key: 1171163 · Received September 23, 2008

    Report

    Report Number
    1022819-2008-00268
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 5, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    PMA / PMN Number
    K982829
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION WAS PERFORMED BY OUR ENGINEERING DEPARTMENT. ROOT CAUSE IS UNKNOWN BECAUSE THE DEVICE PERFORMED TO SPECIFICATION AND TO ITS INTENDED USE. THE ENGINEERING DEPARTMENT DID NOT FIND ANY PROBLEMS WITH THE DEVICE. THE DEVICE LABELING IDENTIFIES ADVERSE EFFECTS; SKIN IRRITATION AND BURNS BENEATH THE ELECTRODES HAVE BEEN REPORTED WITH THE USE OF POWERED MUSCLE STIMULATORS. REFERENCE REPORT: 1022819-2008-00391.

    Description of Event or Problem · 1

    A MALE PATIENT, (B)(6), WAS BEING TREATED FOR LOWER BACK PAIN WITH ELECTROTHERAPY WHEN THE PATIENT EXPERIENCED AN UNINTENDED OUTPUT FROM THE DEVICE. THE PATIENT DID RECEIVE A 2ND DEGREE BURN IN THE AREA OF TREATMENT UNDER ONE OF THE APPLICATION ELECTRODES. THE CLINICIAN WAS USING THE PRE-MOD ELECTROTHERAPY WAVEFORM TO TREAT THE PATIENT. THE CLINICIAN ADJUSTED THE OUTPUT INTENSITY TO PATIENT TOLERANCE. THE TREATMENT TIME WAS FOR 15 MINUTES. THE ELECTRODE SIZE WAS UNKNOWN. THE ELECTRODES HAD BEEN USED ON THE PATIENT FOUR TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELECT CB IPF, GZJ, GZI IPF CHATTANOOGA GROUP INTCB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention