BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEMAN FRONTAL SINUS STENT

    MDR report key: 349872 · Received August 29, 2001

    Report

    Report Number
    2025182-2001-00001
    Event Type
    Injury
    Date Received
    August 29, 2001
    Date of Event
    July 26, 2001
    Report Date
    August 28, 2001
    Manufacturer
    HELIX MEDICAL, INC.
    Product Code
    KAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    - VERBALL DESCRIPTION FROM INITIAL REPORTER: "DEVICE WAS A STAINLESS STEEL INSERTER USED TO PLACE A NASAL STENT. THE TIP BROKE OFF THE INSERTER WHILE IN SITU. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE INSERTER TIP. PT IS DOING WELL." - TAKEN FROM MEDWATCH FORM COMPLETED BY THE INITIAL REPORTER: "WHILE USING FRONTAL SINUS STENT INSTRUMENT, TIP OF INSTRUMENT DETACHED FROM INSTRUMENT AND LODGED IN SINUS. INCISION HAD TO BE MADE TO RETRIEVE TIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39551 FREEMAN FRONTAL SINUS STENT NASAL SINUS STENT/SINUS CANNULA KAM HELIX MEDICAL, INC. NA 620985

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention