BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEVA TRACT

    MDR report key: 18844977 · Received March 6, 2024

    Report

    Report Number
    18844977
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    February 6, 2024
    Report Date
    February 22, 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

    DURING SEPTOPLASTY PORTION OF SURGERY, SINUS BALLOON POPPED AT A PRESSURE OF 4ATM, MANUFACTURER¿S REPORTED PRESSURE MAX SHOULD BE AT 8ATM, PATIENT UNINJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118620 RELIEVA TRACT BALLOON, NASAL AIRWAY QGK ACCLARENT, INC. RT1640A 10705031462649

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male