BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATEC VACUUM ASSISTED BREAST BIOPSY DEVICE

    MDR report key: 1188329 · Received October 3, 2008

    Report

    Report Number
    3003862400-2008-00008
    Event Type
    Other
    Date Received
    October 3, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 1, 2008
    Manufacturer
    HOLOGIC, INC - INTERVENTIONAL BREAST SOLUTIONS DIVISION
    Product Code
    KNW
    PMA / PMN Number
    K042290
    Removal / Correction Number
    3003862400-09/30/08-001-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO HOLOGIC ONE ATEC 1212-20 TIP OF THE DEVICE LEFT INSIDE THE PATIENTS BREAST AFTER BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATEC VACUUM ASSISTED BREAST BIOPSY DEVICE VACUUM ASSISTED CORE BIOPSY DEVICE KNW HOLOGIC, INC - INTERVENTIONAL BREAST SOLUTIONS DIVISION ATEC 1212-20 806066

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention