BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMARK TRAPDOOR SITE IDENTIFICATION SYSTEM

    MDR report key: 1591199 · Received January 27, 2010

    Report

    Report Number
    3003862400-2010-00002
    Event Type
    Other
    Date Received
    January 27, 2010
    Date of Event
    December 31, 2009
    Report Date
    January 26, 2010
    Manufacturer
    HOLOGIC, INC.
    Product Code
    NEU
    PMA / PMN Number
    K023450
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORT FROM CUSTOMER STATES THAT WHEN THE TRIMARK TD 36-09 DEVICE WAS INSERTED INTO THE BIOPSY HANDPIECE, IT "DIDN'T FEEL RIGHT". THE CUSTOMER REPORTS THAT THE TRIMARK TD 36-09 DEVICE WAS BROKEN MIDWAY UP THE TRAP DOOR AND THE BROKEN PORTION WAS LEFT BEHIND IN THE PT'S BREAST.

    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 36-09 911015

    Patients

    Seq Age Sex Outcome Treatment
    1