BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSYS

    MDR report key: 201805 · Received December 11, 1998

    Report

    Report Number
    MW1015221
    Event Type
    Malfunction
    Date Received
    December 11, 1998
    Date of Event
    December 2, 1998
    Report Date
    December 9, 1998
    Manufacturer
    BIOPSYS MEDICAL, INC.
    Product Code
    MJG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    END OF MARKER STYLETTE NOTED TO BE BROKEN AFTER REMOVAL OF THE STYLETTE DURING REMOVAL OF CORE TISSUE SAMPLES DURING A STEREOTACTIC BREAST BIOPSY. PT WAS RADIOGRAPHED DIGITALLY WITH STEREOTACTIC EQUIPMENT. NO CLIP OR BROKEN PLASTIC TIP WAS NOTED IN BREAST. MFR NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPSYS MAMMOTOME NEEDLE/MICRO MARKER CLIP MJG BIOPSYS MEDICAL, INC. C1530 N6049

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR