BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATEC BIOPSY SYSTEM

    MDR report key: 2093878 · Received April 22, 2011

    Report

    Report Number
    3003862400-2011-00001
    Event Type
    Other
    Date Received
    April 22, 2011
    Report Date
    March 28, 2011
    Manufacturer
    HOLOGIC, INC.
    Product Code
    KNW
    PMA / PMN Number
    K042290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATED THAT THE DEVICE WAS NOT USED ON A PT.

    Description of Event or Problem · 1

    AN ATEC (B)(4) WAS ALLEGEDLY DELIVERED WITHOUT A TISSUE FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATEC BIOPSY SYSTEM VACUUM ASSISTED BIOPSY DEVICE KNW HOLOGIC, INC. ATEC 0912-20 010043

    Patients

    Seq Age Sex Outcome Treatment
    1