BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLOGUARD

    MDR report key: 9750420 · Received February 24, 2020

    Report

    Report Number
    MW5093239
    Event Type
    Malfunction
    Date Received
    February 24, 2020
    Date of Event
    February 6, 2020
    Report Date
    February 20, 2020
    Manufacturer
    EXACT SCIENCES CORPORATION
    Product Code
    PHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COLOGUARD TEST IS UNRELIABLE. EXACT SCIENCES "COLOGUARD TEST IS AN INFERIOR PRODUCT THAT LEADS TO VERY HIGH FALSE POSITIVE RESULTS. THEY DO NOT PROVIDE ANY DATA TO THE PT OR PROVIDER, ONLY NEGATIVE OR POSITIVE, WHICH IS NO HELP AT ALL. PTS ARE ENTITLED TO ALL INFO ABOUT ANY MEDICAL TEST OR PROCEDURE, BUT THE RESPONSE FROM EXACT SCIENCES IS THAT THE FDA DOESN'T REQUIRE THEM TO. DR (B)(6) AT (B)(6) HEALTH DOESN'T RECOMMEND COLOGUARD BECAUSE EVIDENCE DOESN'T BACK IT UP. I HAVE FOUND NUMEROUS OTHER SOURCES SINCE RECEIVING A "POSITIVE" RESULT (WITH NOTHING TO BACK IT UP) THAT MOST SURGEONS AND GASTROENTEROLOGISTS CONSIDER COLOGUARD TO BE "GARBAGE." HOW CAN IT POSSIBLY BE THAT THIS PRODUCT IS FDA APPROVED? FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211493 COLOGUARD SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION PHP EXACT SCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other