BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOVIE MEDICAL CORPORATION

    MDR report key: 1027950 · Received April 10, 2008

    Report

    Report Number
    3004421285-2008-00002
    Event Type
    Injury
    Date Received
    April 10, 2008
    Date of Event
    February 18, 2008
    Report Date
    March 17, 2008
    Manufacturer
    BOVIE MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K001382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOVIE RECEIVED A REPORTED INCIDENT OF A PATIENT BURN FROM THE DOCTOR USING AN AARON A2100 ELECTROSURGICAL GENERATOR. PER CONVERSATION WITH THE DOCTOR, THE PATIENT RECEIVED A 3RD DEGREE BURN, ON THE RIGHT THIGH. IT WAS NOT HIS PATIENT AND ANOTHER DOCTOR WAS USING HIS EQUIPMENT IN HIS FACILITY. THEY WERE USING A STICKY PAD LOCATED ON THE RIGHT THIGH, AND HE BELIEVES THE PATIENT HAD SOME SORT OF A SUNTAN LOTION THAT WAS NOT REMOVED COMPLETELY. THERE WAS SOME RESIDUE LEFT ON THE WIPE THAT WAS USED ON THE BURN. HE DOES NOT KNOW THE SETTINGS THAT WERE USED AT THE TIME OF THE PROCEDURE, WHICH WAS AN ABDOMINAL ANGIOPLASTY AND LIPOSUCTION. THE UNIT WAS USED FOR AN HOUR WITH NO PROBLEMS; THEY THEN STARTED GETTING ERROR MESSAGES AND CHANGED TO ANOTHER UNIT. THIS IS WHEN THE BURN OCCURRED. THE DOCTOR SAID A MEDWATCH WAS NOT GOING TO BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOVIE MEDICAL CORPORATION ELECTROSURGICAL GENERATOR GEI BOVIE MEDICAL A2100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other