BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIRTCHER

    MDR report key: 24987 · Received January 10, 1995

    Report

    Report Number
    24987
    Event Type
    Injury
    Date Received
    January 10, 1995
    Date of Event
    May 12, 1994
    Report Date
    May 26, 1994
    Manufacturer
    BIRTCHER MEDICAL SYSTEMS, INC.
    Product Code
    FAR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS TO HAVE TWO LESIONS REMOVED FROM BACK. DURING REMOVAL OF FIRST LESION, THERE WAS ARCING FROM ELECTROSURGICAL UNIT, THEN A FLAME IN THE AREA. PROCEDURE TERMINATED. ICE PLACED ON BACK WHERE FLAMES HAD BEEN. APPEARED TO BE A 6-10 CM. AREA OF 1 ST AND 2 ND DEGREE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIRTCHER ELECTROSURGICAL UNIT FAR BIRTCHER MEDICAL SYSTEMS, INC. 4400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| S DURAPREP - 3M