BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSYS MARKER CLIP WITH INTRODUCER

    MDR report key: 200090 · Received December 1, 1998

    Report

    Report Number
    1527736-1998-03809
    Event Type
    Malfunction
    Date Received
    December 1, 1998
    Date of Event
    November 6, 1998
    Report Date
    November 6, 1998
    Manufacturer
    BIOPSYS MEDICAL, INC
    Product Code
    KNW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN FIRED A CLIP AND THE TIP OR SLEEVE OF THE APPLIER SHEARED OFF IN THE BREAST. THE NURSE AND RADIOLOTIST REMOVED THE TIP OR SLEEVE OF THE APPLIER FROM THE BREAST WITH FORCEPS. THEY BELIEVE THE CLIP REMAINED IN THE BREAST AS IT SHOULD. THE PHYSICIAN PRESCRIBED ANTIBIOTICS FOR THE PT. THERE WAS NOT CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPSYS MARKER CLIP WITH INTRODUCER BIOPSYS KNW BIOPSYS MEDICAL, INC NA W6049

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other