BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISECORE

    MDR report key: 12923424 · Received December 3, 2021

    Report

    Report Number
    1835568-2021-00002
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    October 1, 2021
    Report Date
    December 2, 2021
    Manufacturer
    INRAD, INC.
    Product Code
    KNW
    UDI-DI
    00817295020817
    PMA / PMN Number
    K093399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THREE SMALL METAL PIECES WERE LEFT IN THE BREAST AFTER USING AN INRAD BIOPSY DEVICE, A TUMARK Q CLIP AND A 25G X 1 1/2 BD ECLIPSE NEEDLE. INRAD 14GX10CM-LOT #62101001- REF#681014- EXPIRATION DATE: 01/06/24 HOLOGIC PROFESSIONAL Q SHAPE CLIP- LOT#51612- REF#351222- EXPIRATION DATE: 04/18/26 BD ECLIPSE NEEDLE 25G X 1 1/2 - LOT#1002329- REF#305767 - EXPIRATION DATE: 12/31/25.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825756 PRECISECORE PRECISECORE NO THROW BIOPSY DEVICE KNW INRAD, INC. 681014 62101001 00817295020817

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other