BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGEND XT 2CH COMBO

    MDR report key: 1171156 · Received September 23, 2008

    Report

    Report Number
    1022819-2008-00249
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 4, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IMG
    PMA / PMN Number
    K031077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION WAS PERFORMED BY OUR ENGINEERING DEPT. ROOT CAUSE IS UNKNOWN BECAUSE THE DEVICE PERFORMED TO SPECIFICATION AND TO ITS INTENDED USE. THE ENGINEERING DEPT 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.

    Description of Event or Problem · 1

    THE PATIENT REC'D A SINGLE, 2ND DEGREE BURN AFTER AN ELECTROTHERAPY TREATMENT. THE PT WAS BURNED IN THE AREA OF TREATMENT UNDERNEATH THE ELECTRODE. THE PT SOUGHT URGENT CARE MEDICAL ATTENTION AS A RESULT OF THE INJURY. THE TREATING CLINICIAN PRESCRIBED THE INTERFERENTIAL ELECTROTHERAPY WAVEFORM. THE THERAPY WAS APPLIED TO THE PT'S LEG. THE CLINICIAN ADJUST THE TREATMENT INTENSITY TO PT TOLERANCE. THE TREATMENT TIME WAS SET TO 15-20 MINUTES. THE CLINICIAN LEFT THE PT DURING THE TREATMENT. UPON THE COMPLETION OF THE TREATMENT, HE CLINICIAN RETURNED TO REMOVE THE ELECTRODES FROM THE PT. UPON REMOVAL OF THE ELECTRODES, THE CLINICIAN NOTED REDNESS IN THE AREA OF THE TREATMENT. THE PT HAD NOT COMPLAINED OF PAIN DURING OR AFTER THE TREATMENT. TWO TO THREE DAYS LATER, THE PT REPORTED TO THE CLINIC THAT THE REDNESS IN ONE OF THE ELECTRODES AREAS HAD DEVELOPED INTO A VERY PAINFUL 2ND DEGREE BURN. THE PT REPORTED THAT THEY HAD SOUGHT URGENT CARE MEDICAL ATTENTION AS A RESULT OF THE PAIN AND THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGEND XT 2CH COMBO IMG; GZI, GZJ, IPF IMG CHATTANOOGA GROUP 2760

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention