BEUDAMED
    FDA Adverse Event Other Summary report: N

    ETHICON GYNECARE

    MDR report key: 3770883 · Received April 2, 2014

    Report

    Report Number
    3770883
    Event Type
    Other
    Date Received
    April 2, 2014
    Date of Event
    March 7, 2013
    Report Date
    March 14, 2013
    Manufacturer
    DEVICOR MEDICAL PRODUCTS, INC.
    Product Code
    NEU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RADIOLOGIST ATTEMPTED TO INSERT 8 GAUGE CLIP INTO RIGHT BREAST AT BIOPSY SITE. AFTER UNSUCCESSFUL DEPLOYMENT OF CLIP, A SECOND ATTEMPT WAS MADE WITH A NEW CLIP. THIS SECOND ATTEMPT WAS ALSO UNSUCCESSFUL. POST MAMMOGRAM REVEALED THE TIP OF THE CLIP INTRODUCER HAD SHEARED OFF AND REMAINED IN THE BREAST. PT WILL LIKELY NEED PROCEDURE TO REMOVE FOREIGN BODY. SEE SCANNED PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199759 ETHICON GYNECARE CLIP INTRODUCER MAMMOTOME MAMMOMARK 2 - 8 GAUGE NEU DEVICOR MEDICAL PRODUCTS, INC. MAM 3008 F11228211D1
    199760 ETHICON GYNECARE CLIP INTRODUCER MAMMOTOME MAMMOMARK 2 - 8 GAUGE NEU MAMMOTOME MAM 3008 F11228211D1

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other