BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDOVATIONS M-FLEX SILICONE BOUGIE 54FR

    MDR report key: 11901004 · Received May 27, 2021

    Report

    Report Number
    MW5101618
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    May 24, 2021
    Report Date
    May 26, 2021
    Manufacturer
    DIVERSATEK HEALTHCARE INC.
    Product Code
    FAT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDOSCOPY BOUGIE BEING USED IN SURGICAL CASE WAS BEING REMOVED WHEN THE TIP CAME OFF. THE TIP WAS RETRIEVED, HOWEVER TUNGSTEN POWDER FROM THE BOUGIE WAS NOTED IN THE PT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795041 MEDOVATIONS M-FLEX SILICONE BOUGIE 54FR BOUGIE, ESOPHAGEAL, AND GASTROINTESTINAL, GASTRO-UROLOGY FAT DIVERSATEK HEALTHCARE INC. 1206-54 22410Z

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention