BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MW5062882

    MDR report key: 5728711 · Received June 13, 2016

    Report

    Report Number
    MW5062882
    Event Type
    Injury
    Date Received
    June 13, 2016
    Date of Event
    March 8, 2016
    Report Date
    June 13, 2016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS IS REGARDING THE ONCOBLOT BLOOD TEST WHICH IS CURRENTLY SEEKING FDA APPROVAL WITH A 510 (K) BEING PREPARED FOR SUBMISSION. THE WEBSITE FOR THIS BLOOD TEST IS (B)(6). THROUGH MY PRIMARY CARE PHYSICIAN, DR. (B)(6), WITH THE (B)(6) CLINIC IN (B)(6), I HAD THIS BLOOD TEST DONE. THE RESULTS SHOWED THAT I HAVE PROTEINS EVIDENT FOR BREAST CANCER. I RECEIVED THESE TEST RESULTS FROM DR. (B)(6) ON (B)(6) 2016. ON (B)(6) 2016, I HAD A BREAST MRI WITH CONTRAST DONE AT (B)(6) MEDICAL CENTER IN (B)(6). THE RADIOLOGIST, DR. (B)(6), FOUND NO BREAST CANCER. ON (B)(6) 2016, I HAD A LEFT BREAST BIOPSY DONE UNDER GENERAL ANESTHESIA AT (B)(6) HOSPITAL IN (B)(6). MY SURGEON'S NAME WAS DR. (B)(6). THE BIOPSY WAS DONE ON THE LEFT BREAST AS I DID PALPATE A MASS THERE, HOWEVER, THIS MASS WAS NOTED TO NOT BE CANCER ACCORDING TO DR. (B)(6), THE RADIOLOGIST WHO READ MY MRI. THE PATHOLOGY RESULTS OF THE BREAST BIOPSY WAS, LIKE THE MRI, NEGATIVE FOR CANCER. I'M WRITING TO REPORT ONCOBLOT LABS TO THE FDA FOR ADMINISTERING A BLOOD TEST THAT RENDERED A (B)(6) RESULT, AND SUCH, CAUSED ME MUCH EMOTIONAL ANGUISH AND MONETARY EXPENSE.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R