BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLOGUARD TEST

    MDR report key: 18960188 · Received March 21, 2024

    Report

    Report Number
    MW5153055
    Event Type
    Injury
    Date Received
    March 21, 2024
    Date of Event
    March 4, 2024
    Report Date
    March 19, 2024
    Manufacturer
    EXACT SCIENCE LABORATORIES/EXACT SCIENCES CORPORATION
    Product Code
    PHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    UTILIZED COLOGUARD TEST. RETURNED POSITIVE ABNORMAL. COLONOSCOPY WAS PERFORMED (B)(6) 2024, WITH NOTHING FOUND, INCLUDING NO POLYPS. PER DOCTOR 8 OUT OF 10 ARE FALSE POSITIVE. I AM CONCERNED ABOUT FALSE NEGATIVES, THIS TEST IS NOT A BENEFIT BUT FALSE ASSURANCES OF NO COLON CANCER PRESENT. WOULD LIKE YOU TO FIND OUT WHAT STATS THEY HAVE REGARDING TEST RESULTS. I FEEL THAT THIS (B)(6) TEST IS NOT ACCURATE AND SHOULD NOT BE RECOMMENDED. INFORMED MY PCP DOCTOR OF FINDINGS AND STRONGLY RECOMMEND TO NOT SUGGEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408831 COLOGUARD TEST SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION PHP EXACT SCIENCE LABORATORIES/EXACT SCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention AIRBORNE.| FISH OIL.| MAGNESIUM.| MULTIVITAMIN.| VITAMIN C.