BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSYS MARKER CLIP WITH INTRODUCER

    MDR report key: 200098 · Received December 1, 1998

    Report

    Report Number
    1527736-1998-03803
    Event Type
    Malfunction
    Date Received
    December 1, 1998
    Date of Event
    November 4, 1998
    Report Date
    November 5, 1998
    Manufacturer
    BIOPSYS MEDICAL, INC.
    Product Code
    KNW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A BREAST BIOPSY. IT WAS REPORTED THE MARKER SLEEVE HAD SHEARED OFF IN THE BREAST. THE MARKER HAS BEEN LEFT IN THE BREAST. THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPSYS MARKER CLIP WITH INTRODUCER BIOPSYS KNW BIOPSYS MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other