BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOMARK 2

    MDR report key: 2093493 · Received May 13, 2011

    Report

    Report Number
    2093493
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 13, 2011
    Manufacturer
    DEVICOR MEDICAL PRODUCTS, INC.
    Product Code
    NEU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    DURING STEREOTACTIC BIOPSY, THE PHYSICIAN HAD DIFFICULTY DEPLOYING THE MAMMO MARKER. THE PHYSICIAN ENCOUNTERED PRESSURE AND RESISTANCE WHEN ATTEMPTING TO DEPLOY THE DEVICE. A SECOND CLIP WAS DEPLOYED AND BROKE OFF IN THE PATIENT. THE PLASTIC INTRODUCER WAS LEFT INSIDE THE PATIENT AT THE BIOPSY SITE. AWAITING CONFIRMATION ON WHAT THE SURGEON IS GOING TO DO ABOUT THE PLASTIC SHEARED TIP. THE SALES REP REPORTED THAT THE PHYSICIAN "SHEARED OFF THE PLASTIC INTRODUCER." AS NOTED ABOVE, THE PHYSICIAN REPORTED ENCOUNTERING PRESSURE AND RESISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOMARK 2 MAMMO CLIP-MAMMOTOME-MAMMOMARK 11 NEU DEVICOR MEDICAL PRODUCTS, INC. MAM 3001 H43E24

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR