BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEVA SPIN SIUSPLASTY SYSTEM

    MDR report key: 4894298 · Received July 6, 2015

    Report

    Report Number
    4894298
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 26, 2015
    Report Date
    July 6, 2015
    Manufacturer
    ACCLARENT INC
    Product Code
    LRC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    WHEN INSERTING THE DEVICE INTO THE PATIENT, THE WIRE WOULD NOT BEND. NO PATIENT HARM. ANOTHER DEVICE OBTAINED AND PROCEDURE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435938 RELIEVA SPIN SIUSPLASTY SYSTEM INSTRUMENT, ENT MANUAL SURGICAL LRC ACCLARENT INC * 150220A-CM

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR