BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEVA TRACT

    MDR report key: 19475871 · Received June 6, 2024

    Report

    Report Number
    19475871
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    May 14, 2024
    Report Date
    May 16, 2024
    Manufacturer
    ACCLARENT, INC.
    Product Code
    QGK
    UDI-DI
    10705031462649
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SINUS BALLOON POPPED DURING INFLATION IN PATIENT AROUND PRESSURE OF 10 ATM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6659 RELIEVA TRACT BALLOON, NASAL AIRWAY QGK ACCLARENT, INC. RT1640A 221129A-PC 10705031462649

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male