BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8 G MAMMOMARK

    MDR report key: 1514224 · Received October 20, 2009

    Report

    Report Number
    MW5013114
    Event Type
    Malfunction
    Date Received
    October 20, 2009
    Date of Event
    October 2, 2009
    Report Date
    October 14, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, INC. A J & J CO.
    Product Code
    NEU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    POST BIOPSY, LEFT BREAST STEREOTACTIC, ROUTINE CLIP-PLACEMENT BEFORE RELEASING PT: ATTEMPTED EMPLOY OF THE CLIP, FAILED. SECOND ATTEMPT WAS ALSO A DIFFICULT APPLICATION. A PIECE OF THE PLASTIC APPLICATOR SHEARED OFF. ASSUMPTIVELY, THIS PIECE REMAINED IN THE PT'S BREAST. ATTEMPTED TO LOCATE PIECE, UNSUCCESSFUL. NO VISIBLE ON MAMMOGRAM. SUCCESSFUL BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8 G MAMMOMARK BIOPSY SITE IDENTIFIER NEU ETHICON ENDO-SURGERY, INC. A J & J CO. F4PF2F

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other