BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCE EZ-C

    MDR report key: 614084 · Received June 14, 2005

    Report

    Report Number
    1717344-2005-00083
    Event Type
    Injury
    Date Received
    June 14, 2005
    Date of Event
    February 1, 2005
    Report Date
    May 16, 2005
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: INTERNAL PORT EXCHANGE. PER AN INQUIRY LETTER RECEIVED FROM THE PT'S ATTORNEY: "THE CAUTERIZING EQUIPMENT USED WAS YOUR FORCE EZ-C ELECTROSURGICAL GENERATOR, IN CONJUNCTION WITH A RELIANT VL3607 PT RETURN ELECTRODE. AFTER THE SURGERY, IT WAS DISCOVERED THAT THE PT HAD SUFFERED SEVERE THIRD-DEGREE BURNS ON THEIR BACK, IN THE AREA OF THE GROUNDING PAD. THE BURNS NEVER HEALED. THE PT HAD A NUMBER OF MEDICAL PROBLEMS, BUT THEIR FAMILY AND FRIENDS FEEL THAT CLEARLY THE BURNS HASTENED THEIR DEATH IN 2005." NOTE: ALTHOUGH THE ATTORNEY'S LETTER STATES THE PT'S FAMILY AND FRIENDS FEEL THE BURNS HASTENED THEIR DEATH, A CAUSE OF DEATH HAS NOT BEEN PROVIDED TO THE COMPANY. THEREFORE, BASED ON THE INFORMATION AVAILABLE TO THE COMPANY AT THIS TIME AND THE REPORT THAT THE PT DEATH OCCURRED SEVENTY-TWO (72) DAYS AFTER THE EVENT, CO HAS CONCLUDED THAT THE PT DEATH CANNOT BE REASONABLY LINKED TO THE DEVICE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE EZ-C ELECTROSURGICAL GENERATOR GEI VALLEYLAB * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L