BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME VACUUM BIOPSY SYSTEM

    MDR report key: 721042 · Received April 5, 2006

    Report

    Report Number
    721042
    Event Type
    Malfunction
    Date Received
    April 5, 2006
    Date of Event
    March 14, 2006
    Report Date
    April 5, 2006
    Manufacturer
    BIOPSYS MEDICAL INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EXCESSIVE BLEEDING DURING PROCEDURE, 1200 ML. FILLED VACUUM CANISTER HOUSED INSIDE MAMMOTOME MACHINE, WHICH CAN'T BE VISUALIZED EASILY. THE PATIENT BECAME NAUSEATED, LETHARGIC, AND DIAPHORETIC. BLOOD PRESSURE DROPPED, PROCEDURE ABORTED AND PATIENT TAKEN TO ED IN SAME THE BUILDING. PT. GIVEN INTRAVENOUS FLUIDS AND POTASSIUM AND WAS DISCHARGED HOME LATER THAT NIGHT IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTOME VACUUM BIOPSY SYSTEM VACUUM SYSTEM, BREAST BIOPSY KNW BIOPSYS MEDICAL INC. SCM 12 *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR