BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERIS BALLOON DILATION CATHETER

    MDR report key: 18011918 · Received October 26, 2023

    Report

    Report Number
    18011918
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    September 3, 2023
    Report Date
    September 29, 2023
    Manufacturer
    BRYAN MEDICAL, INC.
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PROCEDURE- FLEXIBLE BRONCHOSCOPY WITH BALLOON DILATION. 10MM AERIS BALLOON DILATION CATHETER: PER DR. THE BALLOON WAS INFLATED WHILE IN THE PATIENT AND THE BALLOON BROKE IN THE PATIENT. PER DR., NO PRODUCT/BALLOON RESIDUAL WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2140455 AERIS BALLOON DILATION CATHETER BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BRYAN MEDICAL, INC. KG1030 1304305F

    Patients

    Seq Age Sex Outcome Treatment
    1 19710 DA Male