BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATEC TRIMARK BIOPSY SITE IDENTIFICATION SYSTEM

    MDR report key: 3093963 · Received April 26, 2013

    Report

    Report Number
    3003862400-2013-00005
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    September 3, 2012
    Report Date
    March 27, 2013
    Manufacturer
    HOLOGIC
    Product Code
    NEU
    PMA / PMN Number
    K023450
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF THE ATEC TRIMARK BIOPSY SITE MARKER NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE EXPIRATION DATE IS NOT KNOWN. THE DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. LOT NUMBER OF THE MARKER NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE MANUFACTURE DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE MARKER AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT PRESENTED TO HER PHYSICIAN AFTER HAVING AN ATEC TRIMARK BIOPSY SITE MARKER PLACED IN HER BREAST ON (B)(6) 2012. REPORTEDLY, "THREE DAYS LATER, SHE HAD AN ITCHY RASH COVERING HER BODY". SHE HAS SEEN SEVERAL DERMATOLOGISTS AND HAS ONLY RECENTLY BEEN DIAGNOSED WITH "AN ALLERGY TO TITANIUM, CALLED LICHEN PLANUS". TREATMENT IS UNK. RESULTS FROM F/U ON (B)(6) 2013 REVEALED THE RASH IS JUST ON HER ARMS. WE HAVE BEEN UNABLE TO OBTAIN ADD'L INFO SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181723 ATEC TRIMARK BIOPSY SITE IDENTIFICATION SYSTEM TRIMARK TD 3609 NEU HOLOGIC ATEC TRIMARK TD3609 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ATEC BIOPSY DEVICE - LOT #UNK