BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMARK BIOPSY SITE IDENTIFICATION SYSTEM

    MDR report key: 2358064 · Received November 28, 2011

    Report

    Report Number
    3003862400-2011-00007
    Event Type
    Other
    Date Received
    November 28, 2011
    Date of Event
    November 7, 2011
    Report Date
    November 22, 2011
    Manufacturer
    HOLOGIC, INC.
    Product Code
    NEU
    PMA / PMN Number
    K023450
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT SHE EXPERIENCED SEVERE ITCHING, A RASH AND COLD SWEATS AFTER THE IMPLANT OF A TRIMARK BIOPSY SITE TISSUE MARKER DEVICE. THE MARKER WILL NOT BE RETURNED FOR EVAL, SO HOLOGIC IS UNABLE TO CONFIRM THIS COMPLAINT. THE MARKER DEVICE IS COMPOSED PRIMARILY OF IMPLANT-GRADE TITANIUM. THIS MATERIAL HAS BEEN TESTED FOR BIOCOMPATIBILITY PER ISO 10993-1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMARK BIOPSY SITE IDENTIFICATION SYSTEM 21 CFR 878.4300 IMPLANTABLE CLIP NEU HOLOGIC, INC. ATEC-TRIMARKTD1312 103020

    Patients

    Seq Age Sex Outcome Treatment
    1