BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMARK TRAPDOOR SITE IDENTIFICATION SYSTEM

    MDR report key: 1620111 · Received February 23, 2010

    Report

    Report Number
    3003862400-2010-00003
    Event Type
    Other
    Date Received
    February 23, 2010
    Date of Event
    January 25, 2010
    Report Date
    February 25, 2010
    Manufacturer
    HOLOGIC, INC.
    Product Code
    NEU
    PMA / PMN Number
    K023450
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT FROM HOLOGIC (B)(4) IDENTIFYING THAT A PIECE OF THE BIOPSY DEPLOYMENT DEVICE WAS BROKEN OFF DURING THE PROCEDURE AND LEFT AT THE BIOPSY SITE INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMARK TRAPDOOR SITE IDENTIFICATION SYSTEM BIOPSY SITE TISSUE MARKER NEU HOLOGIC, INC. TRIMARK TD 36-12 809099

    Patients

    Seq Age Sex Outcome Treatment
    1