BEUDAMED
    FDA Adverse Event Summary report: N

    LIFESOUND

    MDR report key: 691559 · Received February 24, 2006

    Report

    Report Number
    691559
    Date Received
    February 24, 2006
    Date of Event
    October 1, 2005
    Report Date
    February 24, 2006
    Manufacturer
    NOVAMED
    Product Code
    BZW
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    FEMALE PATIENT UNDER GENERAL ANESTHESIA UNDERWENT A PROCEDURE THAT REQUIRED THE USE OF AN ESOPHAGEAL STETHOSCOPE AND ENDOTRACHEAL TUBE. SOME TIME AFTER THE PROCEDURE THE PATIENT COMPLAINED OF VAGUE ABDOMINAL PAIN AS HER FIRST SYMPTOM. TWO WEEKS LATER THE ESOPHAGEAL STETHOSCOPE WAS DETECTED ON A CAT SCAN AND WAS REMOVED VIA AN ENDOSCOPE. UNKNOWN TO THE STAFF, THE STETHOSCOPE DURING THIS CASE WAS SWALLOWED BY THE PATIENT. IT IS SUGGESTED THAT THE MANUFACTURER REEVALUATE THEIR CURRENT DESIGN TO INCORPORATE A MEANS OF PREVENTING THE PATIENT FROM SWALLOWING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESOUND STETHOSCOPE ESOPHOGEAL BZW NOVAMED 1520 18FR *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR