BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INAD

    MDR report key: 12696869 · Received October 26, 2021

    Report

    Report Number
    12696869
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    October 1, 2021
    Report Date
    October 20, 2021
    Manufacturer
    INRAD
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THREE SMALL METAL PIECES WERE LEFT IN THE BREAST AFTER USING AN INRAD BIOPSY DEVICE, INRAD 14GX10CM-LOT #62101001- REF# (B)(4); HOLOGIC PROFESSIONAL Q SHAPE CLIP- LOT#51612- REF#(B)(4); BD ECLIPSE NEEDLE 25G X 1 1/2 - LOT#1002329- REF# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1594647 INAD INSTRUMENT, BIOPSY KNW INRAD 681014 62101001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other