BEUDAMED
    FDA Adverse Event Other Summary report: N

    SECURMARK BIOPSY IDENTIFICATION SYSTEM

    MDR report key: 2213980 · Received July 28, 2011

    Report

    Report Number
    3003862400-2011-00004
    Event Type
    Other
    Date Received
    July 28, 2011
    Date of Event
    September 30, 2010
    Report Date
    October 1, 2010
    Manufacturer
    HOLOGIC, INC.
    Product Code
    NEU
    PMA / PMN Number
    K072913
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE TIP OF THE DEPLOYMENT DEVICE OF A SECURMARK FOR ATEC BIOPSY SITE IDENTIFICATION; DEVICE SHEARED OFF AND WAS LEFT IN A PT'S BREAST. THE DEPLOYMENT DEVICE WAS NOT RETURNED FOR EVAL, SO HOLOGIC IS UNABLE TO CONFIRM THIS COMPLAINT. THE TIP OF THE DEPLOYMENT DEVICE IS COMPOSED PRIMARILY OF NYLON AND PEBAX MATERIAL, JOINED BY AN ADHESIVE. THESE MATERIALS HAVE BEEN TESTED FOR BIOCOMPATIBILITY IN LONG TERM IMPLANTATION PER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURMARK BIOPSY IDENTIFICATION SYSTEM 21 CFR 878.0430 IMPLANTABLE CLIP NEU HOLOGIC, INC. SMARK-ATEC-2S-36-09 0909108A

    Patients

    Seq Age Sex Outcome Treatment
    1