BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEVA

    MDR report key: 6202133 · Received December 23, 2016

    Report

    Report Number
    6202133
    Event Type
    Malfunction
    Date Received
    December 23, 2016
    Date of Event
    October 6, 2016
    Report Date
    November 16, 2016
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCLARENT BALLOON MALFUNCTIONED DURING SINUS PROCEDURE. BALLOON AND HANDPIECE WERE INSPECTED AND WERE COMPLETELY INTACT. MALFUNCTION WAS RELATED TO A SMALL LEAK IN THE BALLOON. HANDPIECE AND PACKAGING WERE SENT TO THE MANUFACTURER FOR INSPECTION AND REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852114 RELIEVA INSTRUMENT, ENT MANUAL SURGICAL LRC ACCLARENT, INC. 150908C-CM

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR