BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATEC BREAST BIOPSY AND EXCISION SYSTEM

    MDR report key: 2464113 · Received February 14, 2012

    Report

    Report Number
    3003862400-2012-00001
    Event Type
    Other
    Date Received
    February 14, 2012
    Date of Event
    January 26, 2012
    Report Date
    February 14, 2012
    Manufacturer
    HOLOGIC, INC
    Product Code
    KNW
    PMA / PMN Number
    K042290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS EVALUATED BY MANUFACTURER AND NO TISSUE FILTER WAS PRESENT AT THAT TIME. IT CANNOT BE CONFIRMED WITH CERTAINTY THAT THE TISSUE FILTER WAS NOT PRESENT AT THE TIME IT WAS RECEIVED BY THE CUSTOMER.

    Description of Event or Problem · 1

    FACILITY REPORTED THAT ALLEGEDLY THE ATEC BREAST BIOPSY AND EXCISION DEVICE WAS DELIVERED WITHOUT A TISSUE FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATEC BREAST BIOPSY AND EXCISION SYSTEM 21 CFR 876.1075 KNW HOLOGIC, INC ATEC 1212-20 110008

    Patients

    Seq Age Sex Outcome Treatment
    1