BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELECT ADVANCED STIM MONOCHROME

    MDR report key: 1213308 · Received October 27, 2008

    Report

    Report Number
    1022819-2008-00305
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 14, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION AND ANY ADDITIONAL FINDINGS WILL BE PROVIDED UPON CONCLUSION OF THE DEVICE EVALUATION. THIS DEVICE IS FOR EXPORT ONLY.

    Description of Event or Problem · 1

    IN 2007, ONE OF OUR CUSTOMERS HAD A PROBLEM WITH THE 2773MS. HIS PATIENT, WHO HE HAS TREATED FOR MANY YEARS, GOT BURNT ON HIS BACK. THE PATIENT IS STILL HEALING FROM THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELECT ADVANCED STIM MONOCHROME IPF, IMG, GZJ, HCC, GZI IPF CHATTANOOGA GROUP 2773MS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention