BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMARKTD BIOPSY SITE IDENTIFICATION SYSTEM

    MDR report key: 2483131 · Received March 5, 2012

    Report

    Report Number
    3003862400-2012-00003
    Event Type
    Other
    Date Received
    March 5, 2012
    Date of Event
    August 9, 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

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVAL, SO HOLOGIC IS UNABLE TO CONFIRM THIS COMPLAINT. NO FURTHER DETAILS WERE PROVIDED TO HOLOGIC REGARDING WHEN/HOW THE BREAKAGE OCCURRED, WHAT PORTION OF THE DEVICE IS ALLEGED TO HAVE BROKEN, THE CIRCUMSTANCES SURROUNDING THE INCIDENT, OR WHETHER OR NOT THE PT WAS INJURED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DEPLOYMENT DEVICE (STAINLESS STEEL) OF AN ATEC TRIMARKTD BIOPSY SITE IDENTIFICATION DEVICE "BROKE" IN BREAST OF PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMARKTD BIOPSY SITE IDENTIFICATION SYSTEM TRIMARK TD 3609 NEU HOLOGIC INC ATEC TRIMARK TD3609 907067

    Patients

    Seq Age Sex Outcome Treatment
    1