BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAVO

    MDR report key: 16673326 · Received April 4, 2023

    Report

    Report Number
    16673326
    Event Type
    Other
    Date Received
    April 4, 2023
    Date of Event
    August 10, 2021
    Report Date
    August 20, 2021
    Manufacturer
    COVIDIEN LP
    Product Code
    FFT
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    OUTPATIENT AT LAB FOR EGD WITH PLACEMENT OF 48 HR PH BRAVO PROBE. DURING PROCEDURE BRAVO PROBE FELL OF DELIVERY SYSTEM IN PATIENT MOUTH AND THEN FELL INTO PATIENT LUNG. ANESTHESIA AND PULMONARY THEN PLACED LM AIRWAY AND PERFORMED BRONCHOSCOPY TO RETRIEVE THIS DEVICE. EGD WITH BRAVO STUDY THEN PERFORMED SUCCESSFULLY. PATIENT RECOVERED WITH NO COMPLAINTS AND WAS DISCHARGED TO HOME AFTER PROCEDURE WITH NO SIGNS OR SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305053 BRAVO ELECTRODE, PH, STOMACH FFT COVIDIEN LP FGS-0636

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown