BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 479912 · Received August 20, 2003

    Report

    Report Number
    479912
    Event Type
    Injury
    Date Received
    August 20, 2003
    Date of Event
    December 1, 2002
    Report Date
    December 1, 2002
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC
    Product Code
    FFZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TRAUMA PT INVOLVED IN A MVA WAS TAKEN TO O.R. FOR AN EXPANDING ABDOMINAL WALL HEMATOMA. BOVIE ELECTROCAUTERY WAS USED TO CAUTERIZE THE LIVER LACERATION. THE ELECTROCAUTERY CORD WAS FOUND TO HAVE A SMALL HOLE IN THE COATING WHICH PRODUCED A VERY SMALL 0.5CM ROUND BURN ON THE PT'S ABDOMEN TO THE LEFT OF THE UMBILICUS. THE BOVIE MACHINE WAS CHECKED AND WAS OK. THE CORD, HOWEVER, WAS LOST IN TRANSPORT TO REPROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BOVIE CORD FFZ ASPEN SURGICAL PRODUCTS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR