BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEVA SPIN SINUPLASTY SYSTEM

    MDR report key: 3831933 · Received April 15, 2014

    Report

    Report Number
    3831933
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE WAS A DEFECTIVE SINUS BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230525 RELIEVA SPIN SINUPLASTY SYSTEM INSTRUMENT, ENT MANUAL SURGICAL LRC ACCLARENT, INC. RSO616M 130124B-CM

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR