BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAE UNKNOWN GENERATOR

    MDR report key: 6213544 · Received December 29, 2016

    Report

    Report Number
    1226420-2016-00200
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 1, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(6) PATIENT INFORMATION INCOMPLETE AND MISSING PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING A TRANSSPHENOIDAL CASE, THE SURGEON REPORTED SALINE RUN OFF DOWN THE PATIENT¿S LEFT NOSTRIL CAUSING A ½ X 1 INCH BURN. THE DEGREE OF THE BURN IS UNKNOWN. THERE WERE NO INTERVENTIONS REPORTED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862551 MAE UNKNOWN GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC MAE UNK GEN

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR