BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 1211574 · Received October 22, 2008

    Report

    Report Number
    1717344-2008-00488
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 26, 2006
    Report Date
    September 29, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED, BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE NOTICE OF LITIGATION AND SUMMONS, THE SURGEON UNDERTOOK SURGICAL TREATMENT OF BIOPSY PROVEN BASAL CELL CARCINOMA ON THE PLAINTIFF'S LEFT TEMPLE. THE PLAINTIFF WAS ADMINISTERED ANESTHESIA BY AN ANESTHESIOLOGIST. DURING THE PROCEDURE, WHILE THE DOCTOR WAS UTILIZING A CAUTERY UNIT, A FIRE IGNITED WHICH SPREAD QUICKLY ACROSS THE PLAINTIFF'S FACE AND HEAD, CAUSING SEVERE BURNS TO THOSE AREAS. TREATMENT OF THE ALLEGED INJURIES AND ANY OTHER DEVICES WHICH MAY HAVE BEEN USED WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE FX-C GENERATOR ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other