BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEVA SPIN

    MDR report key: 3010488 · Received March 15, 2013

    Report

    Report Number
    3010488
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    SURGEON WORKING ON SINUPLASTY PROCEDURE AND BALLOON POPPED.DEVICE NOT USED ON PATIENT / WAS BEING TESTED PRIOR TO USE. DEVICE MALFUNCTIONED, REMOVED FROM FIELD. NO HARM TO PATIENT.OPENED A NEW PRODUCT, PROCEDURE WENT WELL.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?BILATERAL ENDOSCOPIC MAXILLARY SINUSOTOMY USING BALLOON SINUS PLASTY CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110472 RELIEVA SPIN INSTRUMENT, ENT, BALLOON SINUPLASTY LRC ACCLARENT, INC. * 130108A-CM

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR