BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUROS SURGICAL

    MDR report key: 581702 · Received March 15, 2005

    Report

    Report Number
    MW1034918
    Event Type
    Other
    Date Received
    March 15, 2005
    Date of Event
    February 18, 2005
    Report Date
    March 14, 2005
    Manufacturer
    SUROS SURGICAL
    Product Code
    KNW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT WAS USED IN A CLINICAL TRIAL, IN A CLANDESTINE WAY, WITHOUT THEIR KNOWLEDGE OR CONSENT. THE BREAST BIOPSY MACHINE WAS ALTERED, THE HEAD ENGINEERS CAME INTO THE SURGERY ROOM. DR IS A CO-FOUNDER OF THE BIOPSY MFG CORP. THEY USED PT AS HUMAN EXPERIMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUROS SURGICAL BIOPSY MACHINE KNW SUROS SURGICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other