BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEVA TRACT BALLOON DILATION SYSTEM

    MDR report key: 10142702 · Received June 10, 2020

    Report

    Report Number
    MW5094932
    Event Type
    Malfunction
    Date Received
    June 10, 2020
    Date of Event
    June 5, 2020
    Report Date
    June 8, 2020
    Manufacturer
    JOHNSON & JOHNSON MEDICAL DEVICES COMPANY / ACCLARENT, INC.
    Product Code
    QGK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS TAKEN TO THE OPERATING ROOM FOR SEPTOPLASTY AND BILATERAL INFERIOR TURBINATE REDUCTION. DURING THE PROCEDURE, THE SURGICAL TECH PREPARED TO INFLATE THE BALLOON WHEN SHE NOTICED A HOLE SO THE WATER WOULD NOT HOLD. A NEW BALLOON WAS OPENED AND WORKED FINE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605314 RELIEVA TRACT BALLOON DILATION SYSTEM BALLOON, NASAL AIRWAY QGK JOHNSON & JOHNSON MEDICAL DEVICES COMPANY / ACCLARENT, INC. 191213B-PC

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR