BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT 2215 NEEDLE BIOPSY COAXIAL TEMPO

    MDR report key: 9465882 · Received December 12, 2019

    Report

    Report Number
    MW5091639
    Event Type
    Injury
    Date Received
    December 12, 2019
    Date of Event
    November 27, 2019
    Report Date
    December 10, 2019
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    KNW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT AN IMAGE GUIDED PROCEDURE-CT GUIDED FNA/BIOPSY LEFT LUNG UPPER LOBE; INDICATION: LEFT UPPER LOBE LUNG NODULE. POST PROCEDURE CHEST X-RAY SHOWS 2 TINY METALLIC FRAGMENTS AT THE MEDIAL BORDER OF THE NODULE. SEE SCANNED PAGES. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257822 ACT 2215 NEEDLE BIOPSY COAXIAL TEMPO NEEDLE BIOPSY KNW CAREFUSION 2200, INC. ACT 2215

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other