BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATEC TRIMARK BIOPSY SITE IDENTIFICATION SYSTEM

    MDR report key: 2483069 · Received March 5, 2012

    Report

    Report Number
    3003862400-2012-00002
    Event Type
    Other
    Date Received
    March 5, 2012
    Date of Event
    August 26, 2010
    Report Date
    March 5, 2012
    Manufacturer
    HOLOGIC INC
    Product Code
    NEU
    PMA / PMN Number
    K023450
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DISTAL END OF THE DEPLOYMENT DEVICE (STAINLESS STEEL) OF AN ATEC TRIMARK BIOPSY SITE TISSUE MARKER DEVICE SEPARATED FROM THE DEPLOYMENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATEC TRIMARK BIOPSY SITE IDENTIFICATION SYSTEM TRIMARK TD 3609 NEU HOLOGIC INC ATEC TRIMARK TD3609 908068

    Patients

    Seq Age Sex Outcome Treatment
    1