BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE LIGHTED BOUGIE TIP 40

    MDR report key: 9810761 · Received March 9, 2020

    Report

    Report Number
    MW5093628
    Event Type
    Injury
    Date Received
    March 9, 2020
    Date of Event
    January 7, 2020
    Report Date
    March 6, 2020
    Manufacturer
    MEDOVATIONS / DIVERSATEK HEALTHCARE INC.
    Product Code
    FAT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TIP OF A LIGHTED BOUGIE WAS RETAINED IN A PT'S ESOPHAGUS FOLLOWING REMOVAL OF A LIGHTED BOUGIE. THE LIGHTED BOUGIE WAS USED DURING A LAPAROSCOPIC NISSEN PROCEDURE AND THE SEPARATION OF THE TIP WAS NOT RECOGNIZED. ON THE MORNING FOLLOWING SURGERY, PT COMPLAINED OF NAUSEA, VOMITING AND A PAIN SCORE OF 12/10. FOREIGN OBJECT IDENTIFIED IN THE POSTERIOR ORAL PHARYNX AND REMOVED AT BEDSIDE WITH FORCEPS. FOREIGN OBJECT IDENTIFIED AS THE DISPOSABLE TIP OF A LIGHTED BOUGIE. PERMANENT HARM WAS NOT ASSESSED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267535 DISPOSABLE LIGHTED BOUGIE TIP 40 BOUGIE, ESOPHAGEAL, AND GASTROINTESTINAL, GASTRO-UROLOGY FAT MEDOVATIONS / DIVERSATEK HEALTHCARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention