BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELECT XT 2CH COMBO

    MDR report key: 1082282 · Received July 25, 2008

    Report

    Report Number
    1022819-2008-00182
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    December 12, 2004
    Report Date
    June 26, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    PMA / PMN Number
    K031077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TYPE OF DEVICE: IMG, GZJ, GZI. THE DEGREE OF THE BURN AND THE TREATMENT DETAILS WAS NOT RELEASED BY THE OFFICE ADMINISTRATION OF THE CLINIC. THE OFFICE MANAGER DID RELEASE THAT THE WAVEFORM USED DURING TREATMENT WAS THE INTERFERENTIAL TREATMENT WAVEFORM. THE CLINIC DID MENTION THAT THEY FELT THE INCIDENT WAS SPECIFIC TO THE RECENT RECALL/FIELD CORRECTION. RECORDS INDICATE THAT THE DEVICE IS SUBJECT TO THE RECALL/FIELD CORRECTION. THE DEVICES HAVE BEEN RETURNED TO US FOR EVALUATION.

    Description of Event or Problem · 1

    WE WERE TREATING A PT WITH YOUR ELECTROTHERAPY DEVICE AND THE PT WAS BURNED DURING THE ELECTROTHERAPY TREATMENT. THE PT WAS BURNED IN THE AREA OF TREATMENT UNDERNEATH THE TREATMENT ELECTRODES. THE PT DID NOT RETURN FOR FOLLOW UP REGARDING THE INCIDENT OR THE TREATMENT. AT THIS TIME, WE WANT TO REFRAIN FROM RELEASING ANY ADDITIONAL TREATMENT INFO. WE HAVE TWO DEVICES AND WE CAN NOT DETERMINE WHICH DEVICE WAS INVOLVED IN THE INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability