BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLADE ELECTRODE 6.5¿

    MDR report key: 1945185 · Received December 16, 2010

    Report

    Report Number
    1945185
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 10, 2010
    Report Date
    December 16, 2010
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RETAINED FOREIGN BODY LATER IDENTIFIED AS THE CLEAR CAP FROM A BOVIE CAUTERY UNIT WHICH APPARENTLY HAD BEEN USED IN A PREVIOUS ABDOMINAL SURGERY PERFORMED SEVERAL MONTHS AGO. PATIENT LATER COMPLAINED OF INCREASING ABDOMINAL PAIN ABOUT A MONTH AGO, WAS ADMITTED, AND FOREIGN BODY IN ABDOMEN IDENTIFIED ON XRAY. PT TAKEN TO SURGERY FOR EXPLORATORY LAP WHERE CLEAR OBJECT WAS IDENTIFIED AND REMOVED, SENT TO PATHOLOGY, AND LATER IDENTIFIED AS THE CLEAR CAP FROM BOVIE UNIT. SEROMA AROUND THE OBJECT HAD DEVELOPED AND WAS DRAINED.======================HEALTH PROFESSIONAL'S IMPRESSION======================THE CAP ON THE BOVIE UNIT IS CLEAR AND CAN THUS BE MORE EASILY LOST OR NOT SEEN ON THE STERILE SURGICAL FIELD. NOT ALL BOVIE CAUTERY DEVICES REPORTEDLY HAVE SUCH CAPS. FROM A PRODUCT MANUFACTURING STANDPOINT, IT IS RECOMMENDED THAT SUCH CAPS IF USED BE CHANGED FROM CLEAR TO COLORED AND THAT THEY BE RADIOLUCENT FOR EASIER IDENTIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADE ELECTRODE 6.5¿ BOVIE CAUTERY GEI MEDLINE INDUSTRIES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| O| R NO OTHER THERAPIES