BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELECT XT 2CH COMBO PKG

    MDR report key: 3127052 · Received October 15, 2008

    Report

    Report Number
    1022819-2008-00393
    Event Type
    Injury
    Date Received
    October 15, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    PMA / PMN Number
    K031077
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND IS CURRENTLY UNDER EVAL. THE DEVICE EVAL AND ANY ADD'L FINDINGS WILL BE PROVIDED UPON CONCLUSION OF THE DEVICE EVAL. REF REPORT: 1022819-2008-00285, 00392.

    Description of Event or Problem · 1

    PT (B)(6) WAS BURNED IN (B)(6) 2007. THIS MALE WAS APPROX (B)(6) AND WAS BEING TREATED FOR A MUSCLE SPASM. THE PT HAD TENDONITIS IN HIS RIGHT SHOULDER. THE CLIENT DID NOT REMEMBER THE DETAILS OF EACH TREATMENT BUT KNOWS THAT THESE BURNS OCCUR WHEN USING PREMOD OR RUSSIAN WAVEFORMS AND NO OTHERS. THE DEVICE, LEADWIRE, CURRENT ELECTRODES AND A SAMPLE OF THE SAME KIND OF ELECTRODES USED ON (B)(6) WILL BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention