BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLOGUARD

    MDR report key: 15348284 · Received September 1, 2022

    Report

    Report Number
    MW5111847
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Date of Event
    June 22, 2022
    Report Date
    August 30, 2022
    Manufacturer
    EXACT SCIENCES CORP
    Product Code
    PHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I TOOK A COLOGUARD TEST BASED ON FALSE MARKETING THAT IT IS A RELIABLE AND TRUSTWORTHY TEST FOR COLON CANCER. I GOT A "POSITIVE" RESULT WHICH REQUIRED A FOLLOW UP COLONOSCOPY. EXACT SCIENCES ADMITS IN ITS INFORMATION SENT TO THOSE WHO GET A POSITIVE RESULT THAT A STUDY OF 1600 PATIENTS WHO GOT A "POSITIVE" RESULT, ONLY 4% ACTUALLY HAD A CANCEROUS POLYP. THE REMAINDER HAD EITHER NOTHING (APPROXIMATELY 45%) OR HAD A BENIGN POLYP. THIS TEST IS EXPENSIVE AND NOT RELIABLE. IT SHOULD HAVE A MUCH HIGHER RATE OF ACCURACY FOR IT TO BE AN APPROVED TEST. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301352 COLOGUARD SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION PHP EXACT SCIENCES CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other ATORVASTATIN| DILATIAZEM | SENNA| TADALAFIL