BEUDAMED
    FDA Adverse Event Summary report: N

    HURST BOUGIE OR DILATOR

    MDR report key: 12686 · Received April 12, 1994

    Report

    Report Number
    MW1001545
    Date Received
    April 12, 1994
    Manufacturer
    PILLING CO.
    Product Code
    FAT
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE "EXPLORATORY THORACOTOMY, VAGOTOMY, REPAIR HERNIA, LIVER BIOPSY," AN INTACT BOUGIE WAS INSERTED PER ANESTHETIST. ON REMOVAL LEAKAGE WAS NOTED FROM THE BOUGIE. THIS WAS REPORTED TO THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HURST BOUGIE OR DILATOR BOUGIE OR DILATOR FAT PILLING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR